MAHURKAR Elite 8888222320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521126480), received between Aug 3, 2021 and Aug 3, 2021 — classified as 1 malfunction.

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.

• MalfunctionAug 3, 2021Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHEN TRYING TO REMOVE THE GUIDEWIRE, IT SEPARATED AND UNCOILED AND COULD NOT BE RETRIEVED WITHOUT LOSING THE CATHETER IN PATIENT. THEY HAD TO PULL THE CATHETER AND GUIDEWIRE OUT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12266529 ↗

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.