MAHURKAR Elite 8888233420Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521788732), received between Mar 28, 2022 and May 31, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 29, 2026Class IIOpen, 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 · Recall details · FDA record ↗

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.

• MalfunctionMay 31, 2022Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WITH PIGTAIL WAS DISCONNECTED FROM THE PATIENT, THE CLIP DID NOT CLOSE COMPLETELY ON THE RED PORT. THE RED PORT WAS CLAMPED. IT WAS STATED THAT INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 14552384 ↗
• MalfunctionMar 28, 2022Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS DISCONNECTED FROM THE PATIENT, THE CLIP DID NOT CLOSE COMPLETELY ON THE RED PORT. IT WAS STATED THAT THE RED PORT WAS CLAMPED AND WHEN IT WAS DISCONNECTED FROM THE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) MACHINE, AN AIR WAS NOTICED IN THE RED PORT, AND HEMOSTATS WAS THEN QUICKLY USED ON THE RED PORT AND THE AIR WAS WITHDREW WITH A SYRINGE. IT WAS STATED THAT THE CLAMP ON THE PORT WAS NOT FUNCTIONING PROPERLY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928457 ↗

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.