MAHURKAR 8888340629Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521057012), received between Mar 27, 2018 and Sep 16, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

31 other recalls cover devices cleared under the same FDA submission (K020089, K192302); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 28, 2023Class IOpen, 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 ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, WHEN THE CATHETER WAS CONNECTED TO THE DIALYSIS MACHINE, AFTER 10 MINUTES, THEY FOUND A HOLE AT THE JUNCTION OF SILICONE EXTENSION TUBE AND THE RED ADAPTER AND SOME BLOOD WAS ON THE SILICONE EXTENSION. IT WAS STATED THAT FLUSHING WAS DONE, AND THE CATHETER WAS HEPARINIZED WHICH WAS ASPIRATED OUT BEFORE STARTING DIALYSIS WITHOUT PROBLEMS, AND NO LEAKAGE THEN WAS NOTED. IT WAS REPORTED THAT AS LONG AS NO ONE BENT ON THE LEG/ SILICONE EXTENSION, EVERYTHING WORKED FINE, BUT WHEN THE NURSE MARKED THE EXTENSION WITH A LABEL (MARK THE ENTRANCE AS CDK/CENTRAL DIALYSIS CATHETER) AND BENDS IT A LITTLE TO MAKE ROOM WITH THE LABEL, THE HOLE WAS DISCOVERED, AND IN CONNECTION WITH THE BENDING, AIR IS DRAWN INTO THE SYSTEM. THE MACHINE WAS SHUT DOWN AND THELEG/SILICONE EXTENSION WAS ASPIRATED BUT NO AIR HAD ENTERED THE PATIENT. THE CATHETER WAS NOT REPAIRED, CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE CATHETER IN ITS ENTIRETY. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TRE ATED WITH 70% ALCOHOL PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS WERE USED WITH THE DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481297 ↗
• MalfunctionMar 27, 2018Break; Break

  ACCORDING TO THE REPORTER, THE DRESSING WAS FOUND TO BE WET AND A CRACK WAS FOUND AT THE DEVICE¿S CONNECTOR. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7373835 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020089, K192302. One submission often covers many models, so check the product and lot details in each record.

• Z-0423-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
• Z-0426-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
• Z-0424-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
• Z-0425-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
• Z-0422-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
• Z-0421-2026 · Oct 17, 2025 · Open, Classified
  MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
• Z-2391-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
• Z-2370-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
• Z-2385-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
• Z-2388-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
• Z-2375-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
• Z-2376-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
• Z-2374-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
• Z-2367-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
• Z-2389-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP

…and 16 more.