MAHURKAR Elite 8888211230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521125360), received between Mar 10, 2020 and Jul 2, 2025 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE INSERTION OF THE DEVICE'S GUIDEWIRE, FRAYING OCCURRED AT THE TIP OF THE WIRE JUST AFTER PASSING THROUGH THE NEEDLE, MAKING IT IMPOSSIBLE TO ADVANCE OR RETRACT THE WIRE. AFTER SEVERAL ATTEMPTS, IT WAS POSSIBLE TO THREAD OR SUCCESSFULLY REMOVE THE GUIDE WIRE. THE FRAYED GUIDEWIRE DID NOT BREAK INTO PIECES. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE IS USED ON THE DEVICE. AS A REMEDIAL ACTION AND INTERVENTION, A NEW REPLACEMENT GUIDEWIRE WAS USED WITHOUT THE NEED FOR ANOTHER KIT (BY SELLING THE GUIDEWIRE ALONE), AND THIS EXTENDED THE PROCEDURE TIME. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 22384468 ↗
• InjuryMar 10, 2020Product Quality Problem; Obstruction of Flow; Product Quality Problem; Obstruction of Flow

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER INSERTING THE TEMPORARY 30 CENTIMETER CATHETER ON PATIENTS RIGHT SIDE, THEY HAD TROUBLE ASPIRATING BLOOD FROM THE ARTERIAL LUMEN, SO THEY ROTATED THE CATHETER 180 DEGREES AND STILL HAD TROUBLE ASPIRATING FROM THE OTHER LUMEN. IT WAS STATED THAT THE CATHETER WAS OCCLUDED AGAINST THE VESSEL WALL AND MAY BE DUE TO A THROMBOSIS. SINCE THEY WERE NOT ABLE TO GET A GOOD BLOOD RETURN, THEY DECIDED TO INSERT A DIFFERENT CHRONIC DIALYSIS CATHETER THROUGH INTERVENTIONAL RADIOLOGY BUT DID NOT TUNNEL THE CUFF INTO THE SUBCUTANEOUS TISSUE. WITH THE CHRONIC CATHETER IN PLACE, THEY WERE ABLE TO ASPIRATE BLOOD FROM BOTH LUMENS WHICH CONFIRMED THE PATENCY. IT WAS STATED NO ANTI-COAGULANT WAS USED AND FLUSHING WAS DONE PRIOR INSERTION AND RESULTS OF THE FLUSHING WAS COMPLETE (OKAY). IT WAS NOTED THAT THERE WAS NO BLOOD RETURN PRIOR TO SYRINGE FLUSH BUT IT WAS MENTIONED THAT THE LINE WAS NOT HARD TO FLUSH. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO CLEANING AGENT WAS USED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED BLOOD LOSS, NO BLOOD TRANSFUSION WAS DONE AND NO INTERVENTION WAS NEEDED AS A RESULT OF THE EVENT. THE PROCEDURE

  Patient problems: No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 9812707 ↗

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.