MAHURKAR 8888103002HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521128023), received between Oct 24, 2018 and May 20, 2022 — classified as 2 injuries, 1 malfunction.

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 (K102605, 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-2374-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE GUIDEWIRE USED FOR PLACEMENT OF HD (HEMODIALYSIS) LINE BECAME BENT AND FRAYED REQUIRING SURGICAL REMOVAL. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: Insufficient Information

  MAUDE report 14463030 ↗
• MalfunctionNov 15, 2021Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE ON THE RIGHT FEMORAL VEIN, IT WAS SAID THAT GUIDEWIRE COULD NOT BE REMOVED FROM THE HD ( HEMODIALYSIS) CATHETER AND BECAME STRETCHED AFTER SOME PULLING. THE CATHETER WAS REMOVED AND A LARGE HEMATOMA FORMED. PRESSURE WAS HELD AND NO FURTHER COMPLICATIONS OCCURRED. SINCE THE CATHETER PLACEMENT IN THE RIGHT FEMORAL VEIN WAS NOT SUCCESSFUL, THEY HAD TO CHOOSE THE LEFT FEMORAL VEIN. DURING PROCEDURE, NEEDLE WAS INTRODUCED IN THE LEFT FEMORAL VEIN VIA ULTRASOUND GUIDANCE. UNFORTUNATELY, SAME THING HAPPENED WITH THE GUIDEWIRE AND THE CATHETER HAD TO BE REMOVED. THE TWO CATHETERS WERE USED ON THE SAME PATIENT AND OF SINGLE EVENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE/S PRIOR TO USE. THE CATHETERS WERE NOT REPAIRED AND HAD NO LEAK. TEGO WAS NOT UTILIZED. THERE WERE NO LUER ADAPTER ISSUES. PRIOR TO PRODUCT PLACEMENT, THE INSERTION SITES FOR THE RIGHT AND LEFT FEMORAL VEIN WERE DISINFECTED/CLEANED WITH CHLORAPREP - PROVIDED IN THE PRODUCT TRAYS. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICES. BOTH CATHETERS WERE FLUSHED PRIOR TO USE WITH NORMAL RESULTS. THE GUIDEWIRES WERE PART OF KITS BEING USED. THE DIMENSIONS OF THE GUIDEWIRE AND CAT

  Patient problems: Hematoma

  MAUDE report 12817707 ↗
• InjuryOct 24, 2018Break; Break

  ACCORDING TO THE REPORTER, WHILE THE PHYSICIAN WAS INSERTING THE CATHETER, THE GUIDE WIRE SNAPPED. THE PHYSICIAN PLACED A DIFFERENT CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 8001489 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102605, K192302. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-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-2368-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
• Z-2383-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
• Z-2382-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
• Z-2377-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
• Z-2372-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
• Z-2384-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
• 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-2379-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
• Z-2378-2023 · Jun 28, 2023 · Open, Classified
  MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629

…and 16 more.