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MAHURKAR Elite 8888233416Recalls & reported problems

Mozarc Medical US LLC · Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Safety Components · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521788725), received between May 26, 2023 and May 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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

Recalls naming this device

  1. Apr 29, 2026Open, Classified

    The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

    Z-2319-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING NORMAL USE, THE TIP (WHITE PORTION OF THIRD LUMEN) OF THIRD PORT DETACHED FROM THIRD PORT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND NO LUER ADAPTER ISSUE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE ISSUE WAS OBSERVED. CATHETER WAS REMOVED AS THE REMEDIAL ACTION PERFORMED AND THE PROCEDURE WAS PROCEEDED AND COMPLETED AFTER THE REMEDIAL ACTION DONE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17014417 ↗

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-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.