Brevia Dialysis Catheter Kit 5563150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741045424), received between Sep 13, 2019 and Sep 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (1 report).

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.

• MalfunctionSep 13, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE MORNING OF (B)(6) THE MICU REPORTED THEY TRIED TO PLACE A BREVIA TEMPORARY DIALYSIS CATHETER AND THEY HAD AN ISSUE WITH THE GUIDEWIRE AND NEEDLE. PER THE NURSE REPORT: UNABLE TO GET NEEDLE OFF OF GUIDEWIRE AFTER GUIDEWIRE INSERTED. THE NEEDLE WAS STILL IN THE PATIENT AND THE PHYSICIAN WAS UNABLE TO PULL THE NEEDLE BACK, HENCE LEAVING THE GUIDEWIRE IN THE PATIENT. THEY WERE ABLE TO PLACE ANOTHER CATHETER. NO PATIENT HARM REPORTED. ON 8/23/2019 THE RETURNED WIRE WAS FRAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9039722 ↗