MAHURKAR Elite 8888231330Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521127517), received between Jun 26, 2019 and Jun 26, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Product Quality Problem” (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.

• DeathJun 26, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, PROVIDER INSERTED A 30CM CATHETER WHEN HE THOUGHT IT WAS A 20CM, THUS PENETRATING PATIENTS HEART. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO CLEANING AGENTS WAS USED AND THERE WAS NO LUER ADAPTER ISSUE. IT WAS REPORTED THAT PATIENT ENDED UP EXPIRING BUT CAUSE WAS UNKNOWN AS PATIENT HAD MULTIPLE GUNSHOT WOUNDS.

  Patient problems: Death

  MAUDE report 8733473 ↗

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.