Bardex® Silicone Coated Foley Catheter 0166V30SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741039560), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Infuse” (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.

• MalfunctionAug 27, 2018No Device Output; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT WHEN THE BALLOON OF THE FOLEY CATHETER WAS INFLATED, WATER FILLED THE AREA JUST BEFORE THE BIFURCATION ON THE CATHETER WITH MINIMAL FLUID BEING INSTALLED INTO THE ACTUAL BALLOON. WHEN ATTEMPTING TO DEFLATE THE BALLOON BY ATTACHING AN EMPTY SYRINGE, THE FLUID WOULD ALLEGEDLY NOT DRAIN COMPLETELY FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7819379 ↗