MAHURKAR Elite 8888211320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521125971), received between Oct 26, 2022 and Oct 26, 2022 — classified as 1 death.

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.

• DeathOct 26, 2022Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE INSERTION WENT WELL. ONLY ONE STICK WAS PERFORMED AND WHEN THEY PULLED THE GUIDEWIRE, IT WAS OBSERVED THAT IT WAS ALMOST FRAYED. IT EVEN LATCHED ON TO THE SKIN AND THEY HAD TO PULL IT OUT. THE LINE WAS REMOVED, AND THEY INSERTED OUR STANDARD DIALYSIS CATHETER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT (ASIDE FROM THE REPORTED ISSUE). THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND CHLORAPREP WAS USED TO CLEAN THE SKIN PRIOR TO INSERTION. THE GUIDEWIRE AND CATHETER WERE REMOVED FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. ALTHOUGH THE GUIDEWIRE WAS FRAYED, IT WAS REMOVED IN ONE PIECE. THERE WAS NO DAMAGE/DEFECT TO THE CATHETER ITSELF. THE GUIDEWIRE AND CATHETER THAT CAME WITH THE KIT WAS THE ONE USED. THERE WAS NO COMPLICATIONS/SYMPTOMS EXPERIENCE BY THE PATIENT AS THE RESULT OF THE REPORTED GUIDEWIRE EVENT AND THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THE PROCEDURE WAS PROCEEDED AND COMPLETED WITH A NEW (SECOND) CATHETER. THERE WAS NO

  Patient problems: Insufficient Information

  MAUDE report 15672842 ↗

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.