MAHURKAR Elite 8888233320Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521127739), received between Jun 13, 2018 and Nov 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2023Difficult to Remove; Defective Component; Difficult to Remove; Defective Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PHYSICIAN WAS UNABLE TO PULL THE GUIDE WIRE OUT OF THE BLUE LUMEN CAUSING BLOOD TO POUR OUT OF THE PATIENT RESULTING IN THE PATIENT HAVING A HEMATOMA. THERE WAS SOMETHING CATCHING ON THE WIRE RATHER THAN LETTING IT PASS THROUGH THE LUMEN FREELY BUT IT WAS MENTIONED THAT THERE WAS NO VISIBLE DAMAGE NOTED ON THE PRODUCT. THERE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE GUIDEWIRE USED WAS THE ONE INCLUDED IN THE CATHETER KIT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO INSERTION. THERE WAS NO OCCLUSION, THE GUIDE WIRE WAS STILL INTACT WHEN IT WAS REMOVED AND IT WAS NOT NECESSARY TO REMOVE THE GUIDE WIRE AND THE CATHETER FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. THE GUIDE WIRE WAS REMOVED BY HAND AND THERE WERE NO TOOLS USED. THERE WAS NO EXCESSIVE FORCE USED ON INSERTION AND WITHDRAWAL OF THE GUIDE WIRE. ONCE THE PATIENT WAS STABILIZED, THE DEFECTIVE CATHETER WAS EXPLANTED AND A NEW CATHETER WAS PLACED TO RESOLVE THE ISSUE AND PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. AF

  Patient problems: Hematoma

  MAUDE report 18161670 ↗
• MalfunctionJun 13, 2018Break; Material Frayed; Difficult to Remove; Break; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DOCTOR INSERTED THE CATHETER OVER THE WIRE AND UPON RETRIEVAL, THE DOCTOR FELT RESISTANCE AND THE GUIDE WIRE BEGAN TO COME APART, KINK AND UNWIND.

  Patient problems: No Information

  MAUDE report 7597119 ↗

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.