MAHURKAR Elite 8888231220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521127449), received between Nov 18, 2019 and Apr 26, 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.

• MalfunctionApr 26, 2023Break; Break

  ACCORDING TO THE REPORTER, THE REPORTED PRODUCT WAS INSERTED INTO THE LEFT INTERNAL CAROTID ON APRIL 3RD AND IT WAS CONTINUED TO BE USED BUT AT THE NIGHT OF THE EVENT (APRIL 8TH) BLOOD LEAK WAS OBSERVED NEAR THE BRANCHING PART OF THE CATHETER DUE TO SCRATCH, SO BLOOD WAS ATTACHED TO THE PRODUCT. THIS WAS REPORTED TO THE DOCTOR (DR) AND THE REPORTED PRODUCT WAS EXPLANTED AND REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) ON THE SAME DAY. IT WAS STATED THAT WHEN THE REPLACEMENT WAS PERFORMED, IT WAS DETERMINED THAT IT MIGHT HAVE LEAKED BEFORE APRIL 8. THE ISSUE OCCURRED DURING NORMAL USE AFTER THE PROCEDURE WAS COMPLETED AFTER CATHETER INSERTION AND IT WAS UNKNOWN WHETHER IT WAS ACTUALLY DURING DIALYSIS. IT WAS BELIEVED THAT THE TREATMENT HAD BEEN COMPLETED. QB100 MEANT QUANTITY OF BLOOD FLOW OR HOW MUCH BLOOD COULD BE DRAWN PER MINUTE. FLUSHING WAS IMPLEMENTED PRIOR TO USE AND THERE WAS NO ISSUE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. AFTER REMOVING, THE FORCEPS WERE PUT ON THE CATHETER AND PRESSURIZED TO SEE WHERE THE LEAK WAS COMING FROM, AND THERE MIGHT BE A TRACE OF THE FORCEPS SOMEWHERE. THE DEVICE WAS OBSERVED VISUALLY, BUT NO OBVIOUS DAMAGE WAS OBSERVED IN THE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815002 ↗
• InjuryNov 18, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, AN UNSPECIFIED ISSUE WAS NOTED POST FEMORAL ARTERY CATHETER INSERTION. IT WAS STATED THAT THE HEART WAS BEING SPIKED AND THE PATIENT HAD AN ARREST FOR A SHORT TIME. IT WAS MENTIONED IN THE REPORT THAT THE INSERTION SITE WAS TREATED WITH AN UNKNOWN CLEANING AGENT PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Cardiac Arrest

  MAUDE report 9337583 ↗

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.