MAHURKAR Elite 8888222316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521126473), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 death.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

1 FDA recall record name this device's identifier.

1 other recall 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.

Recalls naming this device

1. Oct 14, 2017Class IITerminated

   Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.

   Z-1007-2018 · Root cause: Process control · Recall details · FDA record ↗

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 20, 2021Difficult to Advance; Difficult to Advance

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHEN THE DOCTOR WAS INSERTING THE CATHETER IN INTENSIVE CARE UNIT (ICU) TO START CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT), THE GUIDE WIRE KEPT BENDING AND IT TOOK THREE ATTEMPTS AND THREE DIFFERENT KITS TO PLACE THE LINE. EACH ATTEMPT WAS COMPLETED WITH NEW KIT, NEW CATHETER AND NEW WIRE. THE FIRST KIT THAT HAD THE ISSUE WAS REPLACED BY A SECOND KIT WITH THE SAME LOT WHICH ALSO HAD THE SAME ISSUE. THE THIRD KIT WITH THE SAME ITEM NUMBER WAS USED ON THE SAME DAY OF THE EVENT, IMMEDIATELY FOLLOWING UNSUCCESSFUL ATTEMPTS ON THE FIRST TWO. THE THIRD KIT WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. IT WAS STATED THAT THE BENT/ISSUE WITH THE GUIDE WIRE WAS NOT NOTICED IN THE PACKAGING. THERE WERE NO PIECES TO BE RETRIEVED. THERE WAS A RESISTANCE WHEN INSERTING OR WITHDRAWING THE GUIDEWIRE. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO VISIBLE DEFECT OR DAMAGE WAS NOTED WITH THE CATHETER OR PUNCTURE NEEDLE. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISS

  Patient problems: Insufficient Information

  MAUDE report 12665159 ↗

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