MAHURKAR Elite 8888211424Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521788459), received between Apr 5, 2023 and Jul 14, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

• MalfunctionJul 14, 2023Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow

  ACCORDING TO THE REPORTER, ON THE BACK TABLE BEFORE ANY INSERTION INTO PATIENT, THE CATHETER WAS TESTED FOR INITIAL FLUSH WHICH DID NOT GO THROUGH THE TIP OF BOTH RED AND BLUE LUMENS. THE CATHETER WOULD NOT FLUSH. THERE WAS NO LUMEN EXIT SITE ON DISTAL TIP OF CATHETER VISUALIZED. ON JUNE 28, 2023, THE REP LOOKED AT THE CATHETER THROUGH THE BAG WHERE IT WAS PLACED IN AND NOTICED THERE WERE NO DISTAL SLOTS ON CATHETER. THE CATHETER WAS NOT PROPERLY RESEMBLING ANY DISTAL SIDE SLOTS WHICH INTERNALLY COULD BE A CAUSE FOR NO PROPER FLUSHING. NO VISIBLE CRACKS, CUTS, OR HOLES NOTED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO DIMENSION ISSUE NOTED. THE DIMENSION OF THE CATHETER WAS WHAT WAS INDICATED ON THE LABEL. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES. A NEW VASCULAR CATHETER PACK OF THE SAME REFERENCE NUMBER AND LOT NUMBER WAS OBTAINED ON THE SAME DAY FOR THE PATIENT WITHOUT ANY ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO THROMBOSIS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325198 ↗
• MalfunctionApr 5, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE 13.5-FR, 24-CM VASCATH WAS OPENED UP ON A STERILE TABLE FOR VASCATH PLACEMENT. THE RED PORT OF VASCATH CANNOT BE FLUSHED. THE CATHETER WAS REMOVED, AND ANOTHER ONE WAS USED FOR THE PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16682567 ↗

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.