MAHURKAR 8888135193Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521006492), received between Apr 4, 2019 and Jan 28, 2021 — classified as 1 death, 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.

9 other recalls cover devices cleared under the same FDA submission (K030209, 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. Dec 7, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-0877-2023 · Root cause: Process design · 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.

• MalfunctionJan 28, 2021Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, THE HEMODIALYSIS CATHETER WAS INTRODUCED. HOWEVER, WHEN THE GUIDE WIRE WAS REMOVED, IT GOT STUCK, UNROLLING ALL THE WIRE, AND IT WAS NECESSARY TO REMOVE THE CATHETER WITH THE WIRE, WHICH WAS ALL ROLLED UP AND DEFORMED. THE CATHETER WAS NOT REPAIRED AND NO LEAK. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11242683 ↗
• DeathApr 4, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE NURSE FOUND THAT THE PATIENT HAD PULLED HIS INTERNAL JUGULAR HEMODIALYSIS CATHETER WHICH HAD A LEAK, AND BLOOD WAS SPURTING FROM THE HUB. IT WAS FOUND OUT THAT THE CATHETER REMAINED FULLY INSERTED AND SUTURED IN PLACE. IT WAS STATED THAT RRT WAS CALLED, AND WHILE THE NURSE WAS HOLDING PRESSURE, THE PATIENT BEGAN AGONAL BREATHING AND BECAME UNRESPONSIVE. A CODE BLUE WAS CALLED AND AT THAT TIME PATIENT WAS PULSELESS. COMPRESSION AND CPR (CARDIO-PULMONARY RESUSCITATION) WAS INITIATED, THE PATIENT WAS INTUBATED, AND ACLS (ADVANCED CARDIAC LIFE SUPPORT) PROTOCOL WAS INITIATED. ANOTHER SWAT (SPECIALIZED WORKFORCE FOR ACUTE TRANSPORT) NURSE WHO WAS INVOLVED WITH THE CODE, TOOK OVER HOLDING PRESSURE ON THE NECK AND USED HIS FINGER TO CLAMP THE RIGHT ARM OF THE CATHETER, WHICH WAS MISSING THE HUB AND FROM WHICH BLOOD WAS SPURTING. THE CODE WAS UNSUCCESSFUL AND THE PATIENT EXPIRED.

  Patient problems: Blood Loss; Death

  MAUDE report 8482730 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030209, K192302. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-1955-2019 · Apr 29, 2019 · Terminated
  MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 88156
• Z-0234-04 · Dec 2, 2003 · Terminated
  Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195
• Z-0233-04 · Dec 2, 2003 · Terminated
  Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192