MAHURKAR Elite 8888213216Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521125636), received between Mar 23, 2021 and Feb 5, 2026 — classified as 2 malfunctions.

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

• MalfunctionFeb 5, 2026Unraveled Material

  ACCORDING TO THE REPORTER, A PUNCTURE WAS PERFORMED ACCORDING TO THE OPERATIONAL STANDARD. WHEN USING THE GUIDEWIRE FROM THE HIGH-FLOW CATHETER KIT, THE PHYSICIAN OBSERVED KNOTTING OF THE GUIDEWIRE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. AS A RESULT, IT WAS NECESSARY TO REQUEST A UNILUMEN CATHETER AND ANOTHER HIGH-FLOW CURVED CATHETER KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269775 ↗
• MalfunctionMar 23, 2021Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, AN ATTEMPT WAS MADE TO INSERT THE CATHETER WITH THE GUIDEWIRE, THE PROCEDURE WAS PERFORMED AS USUAL AND WHEN REMOVING THE GUIDEWIRE AFTER POST-IMPLANTATION OF THE CATHETER, IT DID NOT COME OUT. MARKED RESISTANCE WAS OBSERVED WHICH FORCED THE CATHETER AND GUIDEWIRE ASSEMBLY TO BE WITHDRAWN COMPLETELY. AFTER THE REMOVAL, AN UNRAVELLING OF THE GUIDEWIRE WAS OBSERVED AT THE TIP OF THE CATHETER CAUSING THE INTEGRITY OF THE NEEDLE TO BE LOST AND 70% OF IT COMES OUT OF THE LUMEN. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558935 ↗

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.