MAHURKAR Elite 8888233316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521127722), received between Feb 14, 2023 and Feb 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, MD (MEDICAL DOCTOR) WAS UNABLE TO PLACE THE CATHETER OVER THE GUIDEWIRE. IT WOULD STOP RIGHT AT THE HUB AREA OF THE CATHETER. PRODUCT WAS UNABLE TO BE PLACED PROPERLY. THE CATHETER WAS OCCLUDED ONLY WITH PASSAGE OF WIRE. OTHERWISE, CATHETER WAS FLUSHED NORMALLY PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE GUIDE WIRE WAS NOT STUCK, THE GUIDEWIRE WAS ABLE TO BE REMOVED FROM CATHETER WHEN THE WIRE DID NOT PASS THROUGH CATHETER. IT WAS NOT NECESSARY TO REMOVE THE GUIDE WIRE TOGETHER (AT THE SAME TIME) WITH CATHETER. NO TOOLS USED TO REMOVE THE GUIDE WIRE. NO EXCESSIVE FORCE APPLIED ON THE PRODUCT. THE GUIDE WIRE WAS STILL INTACT. THE GUIDE WIRE WAS NOT FRAYED, COILED, UNRAVELED. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THE DIMENSION OF THE DEVICE AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. THERE WAS NO DIMENSION ISSUE NOTED. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371324 ↗

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.