MAHURKARRecalls & reported problems across all models

We found 81 models of MAHURKAR by Mozarc Medical US LLC in the FDA's device registry (GUDID). Together they are named in 962 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2017 and Nov 7, 2025 — classified as 11 deaths, 56 injuries, 895 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (254 reports).

32 FDA recall records name at least one of these models by its device identifier, 32 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MAHURKAR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 17, 2025Open, Classified

   A potential issue with the seal integrity of header bag packaging.

   Z-0426-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. Oct 17, 2025Open, Classified

   A potential issue with the seal integrity of header bag packaging.

   Z-0425-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Oct 17, 2025Open, Classified

   A potential issue with the seal integrity of header bag packaging.

   Z-0424-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Oct 17, 2025Open, Classified

   A potential issue with the seal integrity of header bag packaging.

   Z-0423-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Oct 17, 2025Open, Classified

   A potential issue with the seal integrity of header bag packaging.

   Z-0422-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Oct 17, 2025Open, Classified

   A potential issue with the seal integrity of header bag packaging.

   Z-0421-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Jun 28, 2023Open, Classified

   Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

   Z-2391-2023 · Root cause: Process control · Recall details · FDA record ↗

8. Jun 28, 2023Open, Classified

   Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

   Z-2390-2023 · Root cause: Process control · Recall details · FDA record ↗

9. Jun 28, 2023Open, Classified

   Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

   Z-2389-2023 · Root cause: Process control · Recall details · FDA record ↗

10. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2388-2023 · Root cause: Process control · Recall details · FDA record ↗

11. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2387-2023 · Root cause: Process control · Recall details · FDA record ↗

12. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2386-2023 · Root cause: Process control · Recall details · FDA record ↗

13. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2385-2023 · Root cause: Process control · Recall details · FDA record ↗

14. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2384-2023 · Root cause: Process control · Recall details · FDA record ↗

15. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2383-2023 · Root cause: Process control · Recall details · FDA record ↗

16. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2382-2023 · Root cause: Process control · Recall details · FDA record ↗

17. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2381-2023 · Root cause: Process control · Recall details · FDA record ↗

18. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2380-2023 · Root cause: Process control · Recall details · FDA record ↗

19. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2379-2023 · Root cause: Process control · Recall details · FDA record ↗

20. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2378-2023 · Root cause: Process control · Recall details · FDA record ↗

21. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2377-2023 · Root cause: Process control · Recall details · FDA record ↗

22. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2376-2023 · Root cause: Process control · Recall details · FDA record ↗

23. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2375-2023 · Root cause: Process control · Recall details · FDA record ↗

24. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2374-2023 · Root cause: Process control · Recall details · FDA record ↗

25. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2372-2023 · Root cause: Process control · Recall details · FDA record ↗

26. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2371-2023 · Root cause: Process control · Recall details · FDA record ↗

27. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2370-2023 · Root cause: Process control · Recall details · FDA record ↗

28. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2369-2023 · Root cause: Process control · Recall details · FDA record ↗

29. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2368-2023 · Root cause: Process control · Recall details · FDA record ↗

30. Jun 28, 2023Open, Classified

    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

    Z-2367-2023 · Root cause: Process control · Recall details · FDA record ↗

…and 2 older recalls, listed on each model's page.

Most reported MAHURKAR problems

MAHURKAR models

81 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MAHURKAR 8888135191

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall175 reports
• MAHURKAR 8888135241

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall1 death100 reports
• MAHURKAR 8888101002HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  2 recalls1 death8 reports
• MAHURKAR 8888101003HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  2 recalls4 reports
• MAHURKAR 8888102003HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  2 recalls4 reports
• MAHURKAR 8813793009

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 deaths103 reports
• MAHURKAR 8888102004HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  2 recalls3 reports
• MAHURKAR 8888101001HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  2 recalls0 reports
• MAHURKAR 8888104004HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  2 recalls0 reports
• MAHURKAR 8888145001

  Catheter, hemodialysis, implanted
  1 recall45 reports
• MAHURKAR 8888135161

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall44 reports
• MAHURKAR 8888145251

  Catheter, hemodialysis, implanted
  1 recall1 death33 reports
• MAHURKAR 8888135131

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall28 reports
• MAHURKAR 8813817009

  Catheter,intravascular,therapeutic,short-term less than 30 days
  73 reports
• MAHURKAR 8888135132

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall22 reports
• MAHURKAR 8888345629

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall22 reports
• MAHURKAR 8888135162

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall1 death21 reports
• MAHURKAR 8888135133

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall12 reports
• MAHURKAR 8888145002

  Catheter, hemodialysis, implanted
  1 recall12 reports
• MAHURKAR 8888345611

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall11 reports
• MAHURKAR 8888123435

  Catheter, hemodialysis, implanted
  1 recall10 reports
• MAHURKAR 8888145252

  Catheter, hemodialysis, implanted
  1 recall9 reports
• MAHURKAR 8888340629HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall8 reports
• MAHURKAR 8888135163

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall7 reports
• MAHURKAR 8888345603

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall7 reports
• MAHURKAR 8888345611HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall6 reports
• MAHURKAR 8888345629HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall6 reports
• MAHURKAR 8888103002HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall3 reports
• MAHURKAR 8888135192

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall2 reports
• MAHURKAR 8888135193

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall1 death2 reports
• MAHURKAR 8888135194

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall2 reports
• MAHURKAR 8888345637

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall2 reports
• MAHURKAR 8888145003

  Catheter, hemodialysis, implanted
  1 recall2 reports
• MAHURKAR 8888340629

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall2 reports
• MAHURKAR 8888123402

  Catheter, hemodialysis, implanted
  1 recall1 report
• MAHURKAR 8888340637

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall1 report
• MAHURKAR 8888101004HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall1 report
• MAHURKAR 8888345637HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall1 report
• MAHURKAR 8888145254

  Catheter, hemodialysis, implanted
  1 recall1 report
• MAHURKAR 8888135134

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888135164

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888135242

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888135243

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888119385

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888128485

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888133535

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888145004

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888145253

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888119362

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888128452

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888133502

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888145027

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888145028

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888145029

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888145030

  Catheter, hemodialysis, implanted
  1 recall0 reports
• MAHURKAR 8888135198

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888340637HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888345512HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888345520HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888345603HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888104004HP

  Catheter, hemodialysis, triple lumen, non-implanted
  1 recall0 reports
• MAHURKAR 8888103004HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8888104003HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 recall0 reports
• MAHURKAR 8813793013

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 death43 reports
• MAHURKAR 8831661001

  Catheter,intravascular,therapeutic,short-term less than 30 days
  40 reports
• MAHURKAR 8830415001

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 deaths31 reports
• MAHURKAR 8830415003

  Catheter,intravascular,therapeutic,short-term less than 30 days
  20 reports
• MAHURKAR 8813817005

  Catheter,intravascular,therapeutic,short-term less than 30 days
  14 reports
• MAHURKAR 8813794009

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• MAHURKAR 8832539001

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports
• MAHURKAR 8817143005

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• MAHURKAR 8817146001

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• MAHURKAR 8830414002

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• MAHURKAR 8832539003

  Catheter,intravascular,therapeutic,short-term less than 30 days
  2 reports
• MAHURKAR 8817145005

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• MAHURKAR 8830414001

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• MAHURKAR 8830416003

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• MAHURKAR 8888135167

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 report
• MAHURKAR 8888135197

  CATHETER, HEMODIALYSIS, NON-IMPLANTED
  1 report
• MAHURKAR 8832539002

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 report
• MAHURKAR 8888102003HP

  CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
  1 report

Recent MAHURKAR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THERE WAS A BREAKAGE OF THE TUNNEL PIN. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500659 ↗
• MalfunctionOct 15, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE PROCEDURE, DURING THE COMPLETION OF CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY), THE MEDICAL STAFF OBSERVED A SMALL CRACK AND RUPTURE AT THE CATHETER TIP (LUER ADAPTER), ALLOWING FLUID TO LEAK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. FORTUNATELY, AS THE TREATMENT WAS JUST CONCLUDING, NO ADVERSE OUTCOMES OCCURRED. SINCE THE PATIENT REQUIRED SUBSEQUENT HEMODIALYSIS, THE CATHETER WAS REPLACED AS A REMEDIAL ACTION, AND INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THE TREATMENT WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23281102 ↗
• MalfunctionSep 8, 2025Break; Device Markings/Labelling Problem; Break; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, BEFORE USE ON THE PATIENT, DURING PERMEABILITY TESTING, THE EXPIRY DATE AND LOT INFORMATION WERE NOT LEGI BLE, AND THEREFORE IT CANNOT BE DISPENSED TO THE SERVICE. THE REMEDIAL ACTION PERFORMED WAS TO REPLACE THE PRODUCT. THE UNUSUAL THING OBSERVED ON THE DEVICE WAS A CRACK AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998827 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT WITH UREMIA UNDERWENT PLACEMENT OF A TEMPORARY INGUINAL CHRONIC CARBOTHANE CATHETER FOR HEMODIALYSIS ON (B)(6). FOLLOWING CATHETER INSERTION, REGULAR HEMODIALYSIS WAS INITIATED. ON (B)(6), THE PATIENT DEVELOPED FEVER AND CHILLS, WITH A MAXIMUM BODY TEMPERATURE OF 39.5°C. PHYSICAL EXAMINATION REVEALED COARSE BREATH SOUNDS IN BOTH LUNGS WITHOUT OBVIOUSLY OR MOIST RALES. A SMALL AMOUNT OF PURULENT FLUID WAS OBSERVED AT THE INGUINAL CATHETER SITE. AUXILIARY TESTS SHOWED ON (B)(6) AT 08:18 THAT THE WHITE BLOOD CELL COUNT WAS 13.86×10^9/L, THE NEUTROPHIL PERCENTAGE WAS 91.8%, AND THE PROCALCITONIN WAS 0.18 NG/ML, SUGGESTING A POSSIBLE CATHETER-RELATED INFECTION. THE CATHETER WAS REMOVED, AND PURULENT FLUID WAS SENT FOR BLOOD CULTURE, WHICH GREW STAPHYLOCOCCUS AUREUS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIB

  Patient problems: Bacterial Infection; Chills; Fever; High White Blood Cell Count

  MAUDE report 22945470 ↗
• MalfunctionAug 15, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN THE CATHETER WAS INSERTED, IT WAS WITHOUT COMPLICATIONS, BUT WHEN REMOVING OR WITHDRAWING THE GUIDE, IT WAS OBSERVED THAT IT PRESENTED RESISTANCE TO EXIT, SO FORCE WAS USED TO TRY TO REMOVE THE GUIDE. THIS ATTEMPT WAS MADE SEVERAL TIMES, AND WHEN REMOVING THE GUIDE, IT WAS OBSERVED THAT IT WAS FRAYED AND SEEN TO BE SPLIT IN SOME PARTS. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. CLORHEXIDINA WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED BY HAND. UPON NOTICING THAT THE GUIDEWIRE WOULD NOT COME OUT, AS A REMEDIAL ACTION, IT WAS NECESSARY TO REMOVE THE ENTIRE CATHETER WITH THE GUIDEWIRE STILL INSIDE (INTACT). NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THERE WAS NO BLOOD LOSS, AND THERE WAS NO BLOOD TRANSFUSION DUE TO THE EVENT. THE EVENT DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822252 ↗
• MalfunctionAug 8, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, A LEAKAGE WAS FOUND AT THE SILICONE IV CONNECTOR, FROM THE VENOUS SITE OF THE CATHETER (JUNCTION OF EXTENSION TUBE AND BIFURCATE) BEFORE SURGERY. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, IT WAS REPLACED WITH A NEW PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22752172 ↗
• MalfunctionJul 28, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT ARTERIOVENOUS (AV) FISTULA CREATION AND RECEIVED A CATHETER KIT FOR HEMODIALYSIS ACCESS ON (B)(6) 2025, DUE TO UREMIA AND USED IT FOR VASCULAR ACCESS TO FACILITATE HEMODIALYSIS TREATMENT. ON (B)(6) 2025 THE FIRST SESSION COMMENCED AND INITIALLY PROCEEDED SMOOTHLY. HOWEVER, AFTER 1 HOUR AND 40 MINUTES, THE CATHETER BLOOD DRAINAGE WAS VERY POOR, AND THE MACHINE FREQUENTLY ALARMED. HEMODIALYSIS TREATMENT COULD NOT BE PERFORMED, AND THE HEMODIALYSIS WAS TERMINATED EARLY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS REPAIRED. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22625790 ↗
• MalfunctionJul 25, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE SECOND DIALYSIS SESSION USING THE SAME CATHETER WAS PERFORMED ON (B)(6) 2025, WITH A PLANNED DURATION OF FOUR HOURS. DURING THE THIRD HOUR OF DIALYSIS, BLOOD FLOW DETERIORATED, TRIGGERING REPEATED MACHINE ALARMS. DESPITE MULTIPLE ADJUSTMENTS TO OPTIMIZE CATHETER POSITION AND BLOOD FLOW, THE CONDITIONS FOR EFFECTIVE HEMODIALYSIS WERE NOT MET. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. TEGO WAS NOT UTILIZED. ASIDE FROM THE REPORTED ISSUE, THERE WERE OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE SESSION WAS TERMINATED PREMATURELY AS A REMEDIAL ACTION. THE TREATMENT WAS NOT COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22608412 ↗
• MalfunctionJul 23, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN FLUSHING, IT WAS FOUND THAT THE CATHETER HAD A WATER LEAKAGE FROM THE IV (INTRAVENOUS) CONNECTOR SILICONE TUBING (EXIT SITE) NEAR LUER ADAPTER. IT WAS ALSO STATED THAT THERE WAS A SMALL HOLE IN THE IV CONNECTOR SILICONE TUBING. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE ASIDE FROM THE ISSUE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO DAMAGE TO THE EXTERNAL PACKAGING. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH A NEW CATHETER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583493 ↗
• MalfunctionJul 21, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PHYSICIAN PERFORMED A HEMODIALYSIS CATHETER PLACEMENT. DURING THE PROCEDURE, CONTINUOUS BLOOD LEAKAGE WAS OBSERVED FROM THE CATHETER SHAFT DUE TO SMALL PERFORATIONS. THE CATHETER WAS NOT REPAIRED. A TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE CATHETER WAS IMMEDIATELY REMOVED, AND A NEW PRODUCT WAS PREPARED AND REINSERTED AS AN INTERVENTION, AND THE PROCEDURE WAS COMPLETED. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560615 ↗
• MalfunctionJul 18, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, EARLY THE NEXT MORNING, BLEEDING RECURRED FROM THE CATHETER. EXAMINATION REVEALED A PINHOLE-LIKE CRACK IN THE CATHETER WALL WITH BLEEDING. THE UPPER SEGMENT OF THE CATHETER WAS CLAMPED TO CONTROL BLEEDING. ON (B)(6) THE CATHETER SEGMENT WAS REPLACED, AND NO FURTHER BLEEDING WAS OBSERVED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22542387 ↗
• MalfunctionJul 16, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE GUIDEWIRE HAD MEMORY LOSS DURING THE FIRST PASSAGE, WITH FOLDS AND ANGLES THAT IMPEDE AND HINDER THE PROGRESSION OF THE CATHETER AND INCREASE THE RISK OF LOCAL PUNCTURE COMPLICATIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523391 ↗
• MalfunctionJul 15, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE PATIENT HAD CHRONIC KIDNEY DISEASE AND WAS REGULARLY UNDERGOING HEMODIALYSIS AT THE HOSPITAL. ON (B)(6) 2025, A CATHETER KIT WAS IMPLANTED FOR VASCULAR ACCESS AND BLOOD WITHDRAWAL TO FACILITATE HEMODIALYSIS. THE FIRST USE OF THIS CATHETER OCCURRED ON (B)(6) 2025, FOR A SESSION THAT LASTED 1 HOUR AND 30 MINUTES. DURING THIS PROCEDURE, BLOOD FLOW THROUGH THE CATHETER WAS POOR, AND THE MACHINE FREQUENTLY ALARMED, PREVENTING CONTINUATION OF THE DIALYSIS, WHICH WAS TERMINATED EARLY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE AND WITH NORMAL RESULTS. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE PATIENT'S MEDICATION REGIMEN INVOLVED AN INITIAL DOSE OF 10 MG OF HEPARIN ADMINISTERED VIA ARTERIAL INJECTION, FOLLOWED BY CONTINUOUS ARTERIAL INFUSION AT A RATE OF 3.5 MG/HOUR. THE TOTAL DOSAGE ADMINISTERED OVER THE COURSE OF TREATMENT WAS 10.5 MG, AS THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. ASIDE FRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22515580 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, THE CATHETER WAS USED FOR A SECOND DIALYSIS SESSION. DESPITE ADJUSTMENTS, BLOOD FLOW REMAINED INADEQUATE, AND THE MACHINE REPEATEDLY ALARMED, MAKING IT IMPOSSIBLE TO PERFORM EFFECTIVE DIALYSIS. AS A RESULT, THE PATIENT ONLY RECEIVED A BRIEF DIALYSIS SESSION, INSUFFICIENT FOR ADEQUATE TREATMENT. THE DIALYSIS WAS PREMATURELY TERMINATED, SHORTENING THE SESSION DURATION AND AUTOGENOUS ARTERIOVENOUS FISTULA WAS PLANNED AS AN ALTERNATIVE VASCULAR ACCESS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22515267 ↗
• MalfunctionJul 14, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT WAS ADMITTED TO THE NEPHROLOGY WARD OF THE HOSPITAL ON (B)(6) 2025, AT 15:24:09, DUE TO STAGE 5 CHRONIC KIDNEY DISEASE. FOLLOWING ADMISSION, A CHRONIC CATHETER WAS PLACED FOR HEMODIALYSIS, AND THE CATHETER WAS REGULARLY REPLACED DURING THE HOSPITAL STAY. ON THE DAY OF THE EVENT AT 16:50:00, THE PATIENT'S FAMILY REPORTED THE SUDDEN APPEARANCE OF MINOR BLOOD EXTRAVASATION AT THE VENOUS END OF THE DIALYSIS CATHETER WITHOUT ANY APPARENT TRIGGER. THE NURSE INSPECTED THE CATHETER AND FOUND NO OBVIOUS CRACKS; AFTER SEALING AND DRESSING THE CATHETER, NO FURTHER BLEEDING WAS OBSERVED. HOWEVER, EARLY THE NEXT MORNING, BLEEDING RECURRED FROM THE CATHETER. EXAMINATION REVEALED A PINHOLE-LIKE CRACK IN THE CATHETER WALL WITH BLEEDING. THE UPPER SEGMENT OF THE CATHETER WAS CLAMPED TO CONTROL BLEEDING. ON (B)(6), THE CATHETER SEGMENT WAS REPLACED, AND NO FURTHER BLEEDING WAS OBSERVED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494566 ↗

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