MAHURKAR Elite 8888233313Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521127715), received between Aug 28, 2020 and Aug 28, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2020Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN THE SURGEON WAS INSERTING THE LUMEN EMERGENT HEMODIALYSIS CATHETER, THE GUIDE WIRE WAS SPIRALED AS IT WAS PULLED OUT. IT WAS MENTIONED THAT THE CATHETER WAS PLACED (GUIDE WIRE WAS SUCCESSFULLY INSERTED) BUT AS THE PROVIDER WAS WITHDRAWING THE WIRE FROM THE CATHETER, A RESISTANCE WAS FELT. GENTLE TRACTION WAS TRIED AND AGAIN FELT RESISTANCE, SO THE PROVIDER WITHDREW ALL THAT AT TANDEM TOGETHER. AFTER IT WAS WITHDREW, THE WIRE WAS NOTICED TO HAVE BEEN LOOSE. PROVIDER EXAMINED THE WIRE AND THERE WAS NO PIECE LEFT INSIDE, BOTH TIPS WERE INTACT. A STAT CHEST X-RAY WAS ORDERED TO ASCERTAIN THAT THERE WAS NO FOREIGN BODY LEFT AND IT WAS CONFIRMED THAT THERE WAS NO FOREIGN BODY LEFT. IT WAS MENTIONED THAT THE DEVICE HAD A MALFUNCTION THAT IT DID NOT DO WHAT IT WAS SUPPOSED TO DO. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO EXCESSIVE FORCE USED TO PULL/TAKE OUT THE PRODUCT AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT AND THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10467974 ↗

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.