MAHURKAR Elite 8888231320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521127494), received between Jan 6, 2021 and Jan 6, 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.

• MalfunctionJan 6, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE, IT APPEARED THAT WAS SNAGGED ON A VEIN AND BEGAN TO UNCOIL/KINK. IT WAS REPORTED THAT THEY NEVER HAD DIFFICULTY INSERTING IT, LINE WENT IN EASILY, SLIGHT PRESSURE WITH DILATIONS BUT NOT TOO MUCH, BUT WHEN THEY WENT TO REMOVE AND IT SHREDDED. THEY COULD NOT PULL IT OUT (SMALL KINK) AND HAD TO REMOVE ENTIRE WIRE AND LINE. IT WAS STATED THAT THIS HAPPENED TWO TIMES (INTERNAL JUGULAR AND FEMORAL). THEY HAD TO CALL SURGERY AND THE SAME THING HAPPENED TO THEM TWICE AND THEY GOT IT ON THIRD TIME. IT WAS STATED THAT THE GUIDEWIRE WAS STILL INTACT WHEN REMOVED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11124849 ↗

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.