MAHURKAR Elite 8888221420 (UDI 10884521126435)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521126435), received between Jun 23, 2020 and Nov 10, 2020 — classified as 1 death, 2 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K120674); 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.

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.

• DeathNov 10, 2020Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, THE PATIENT WAS IN THE CRITICAL CARE UNIT AND THE HAEMODIALYSIS (HD) LINE WAS BEING PLACED IN THE PATIENT'S RIGHT FEMORAL ARTERY TO BEGIN RENAL REPLACEMENT THERAPY FOR WORSENING UREMIA. THE VEIN WAS ACCESSED USING BEDSIDE ULTRASOUND AND THE WIRE WAS FED INTO THE NEEDLE WITHOUT ISSUE. THE NEEDLE WAS THEN REMOVED AND A MANOMETRY CATHETER WAS INSERTED AND POSITION WAS CONFIRMED. THE WIRE WAS REMOVED AND VENOUS BLOOD FLOW WAS CONFIRMED ON MANOMETRY BASED ON THE PRESSURE. THE WIRE WAS THEN REINTRODUCED INTO THE FEMORAL VESSEL THROUGH THE MANOMETRY CATHETER AND PLACEMENT WAS CONFIRMED WITH ULTRASOUND. THE SOFT TISSUE WAS DILATED TWICE AND THE HD CATHETER WAS THEN PLACED OVER THE WIRE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE THEY EXPERIENCED RESISTANCE, SO ADJUSTED THE ANGLE BUT STILL EXPERIENCED RESISTANCE. THE CATHETER WAS THEN REMOVED HALFWAY OUT OF THE VESSEL AND WHEN THE WIRE WAS PULLED BACK IT WAS NOTED TO BE SHEARED. THE WIRE COULD NOT BE REMOVED ANY FURTHER SO THE CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER. ONCE REMOVED, IT WAS NOTED THAT THE TIP OF THE WIRE WAS INTACT BUT THE CENTER HAD SHEARED. IT WAS NOT THOUGHT THAT THE WIRE HAD FRAGMENTED,

  Patient problems: No Code Available; Unintended Radiation Exposure

  MAUDE report 10820361 ↗
• MalfunctionOct 8, 2020Break; Physical Resistance/Sticking

  THIS REPORT IS REGARDING THE PLACEMENT OF A RIGHT FEMORAL HEMODIALYSIS (HD) LINE. SUMMARY: WIRE SHEARED UPON REMOVAL THROUGH CATHETER. WHILE THE VEIN WAS BEING ACCESSED USING BEDSIDE ULTRASOUND IN THE CRITICAL CARE UNIT, THE WIRE WAS FED INTO NEEDLE WITHOUT ISSUE. THE NEEDLE WAS THEN REMOVED. THE CATHETER WAS PLACED CONFIRMED USING MANOMETRY OVER A FLEXIBLE WIRE. THE WIRE WAS REMOVED. VENOUS BLOOD WAS CONFIRMED ON MANOMETRY [BASED UPON THE PRESSURE]. THE WIRE WAS REINTRODUCED INTO THE FEMORAL VESSEL THROUGH THE MANOMETRY CATHETER. THE WIRE PLACEMENT WAS CONFIRMED WITH ULTRASOUND. SOFT TISSUE WAS DILATED X 2. THE HD CATHETER WAS PLACED OVER WIRE. WHEN THE WIRE WAS ATTEMPTED TO BE PULLED BACK, THERE WAS RESISTANCE. THE OPERATOR TRIED TO CHANGE THE ANGLE. THERE WAS STILL RESISTANCE. CONSEQUENTLY, THE CATHETER WAS PULLED OUT HALFWAY OUT OF THE VESSEL WITH WIRE REMAINING INSIDE THE CATHETER. NEXT, THE WIRE WAS PULLED BACK AND WAS NOTED TO BE SHEARED. THE WIRE COULD NOT BE PULLED BACK FURTHER. IN ENTIRETY, THE CATHETER AND WIRE WERE REMOVED. THE TIP OF THE WIRE WAS STILL INTACT, AND THE MIDDLE OF THE WIRE HAD BEEN SHEARED. A SECOND WIRE WAS USED TO PLACE A CATHETER USING THE SAME ACCESS

  Patient problems: Insufficient Information

  MAUDE report 10648170 ↗
• MalfunctionJun 23, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, THEY SAID THAT THE CATHETER HAD A FAILED ASPIRATE/ASPIRATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 10185338 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120674. One submission often covers many models, so check the product and lot details in each record.

• Z-2319-2026 · Apr 29, 2026 · Open, Classified
  Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen
• Z-1007-2018 · Oct 14, 2017 · Terminated
  MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.