MAHURKAR Elite 8888231324Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521127500), received between Jun 13, 2018 and Mar 22, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING INSERTION WHILE THE MEDICAL DOCTOR WAS REWIRING THE LEFT FEMORAL CENTRAL LINE FOR A TRIALYSIS LINE, THE DISTAL END OF THE GUIDEWIRE BROKE INTO 2 PIECES AND REMAINED IN THE CENTRAL LUMEN OF THE TRIALYSIS LINE. THE PORT OR THE MIDDLE ACCESS SITE (BROWN) WAS CLAMPED, LABELED, AND CAPPED TO PREVENT DISLODGEMENT OF THE WIRE. THE BROKEN PIECES WERE LEFT INSIDE THE PATIENT'S BODY. CONTINUOUS RENAL REPLACEMENT THERAPY WAS INITIATED PER ORDER AND VASCULAR SURGERY WAS CONSULTED FOR LINE REMOVAL. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH CHLORHEXIDINE PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO ABNORMAL CONDITIONS NOTED PRIOR TO THE ISSUE. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. FLUSHING WAS DONE BY USING A SALINE SOLUTION AND HAD A NORMAL RESULT. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THERE WAS NO OCCLUSION. THERE WAS NO EXCESSIVE FORCE USED ON INSERTION AND WITHDRAWAL OF THE GUIDE WIRE. IT WAS NOT NECESSARY TO REMOVE THE GUIDE WIRE AND NEEDLE IN ONE ACTION

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 16591885 ↗
• MalfunctionJun 13, 2018Break; Difficult to Remove; Break; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS RESISTANCE ON THE WIRE WHEN THE DOCTOR WAS RETRIEVING IT AFTER PLACEMENT AS WELL AS DURING INSERTION. UPON RETRIEVAL, THE WIRE FELL APART. IT WAS ALSO REPORTED THAT THERE WAS A SIGNIFICANT FORCE REQUIRED TO REMOVE THE GUIDE WIRE.

  Patient problems: No Information

  MAUDE report 7597379 ↗

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.