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MAHURKAR Elite 8888231316Recalls & reported problems

Mozarc Medical US LLC · Acute Triple Lumen Catheter Tray Straight Extensions with IC Components · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521127487), received between May 1, 2018 and May 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Operates Differently Than Expected1

Patient problems

  • Blood Loss1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 1, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    ACCORDING TO THE REPORTER, DURING USE, WHEN THE PATIENT RETURNED TO LYING POSITION AFTER SITTING UP ON BED, BLOOD WAS NOTICED AT THE LOCATION OF THE CATHETER. IT WAS FOUND THAT THE CATHETER WAS OUT AND THE SUTURE WING REMAINED ATTACHED TO THE SKIN OF THE PATIENT. THE INTENSIVE CARE UNIT (ICU) AND PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) NURSE REPORTED THAT THE CATHETER CAME OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: Blood Loss

    MAUDE report 7476540 ↗

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.

Other CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED devices

All CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.