Bard Vertus Foley Catheter 0165B16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741099212), received between Feb 14, 2020 and Feb 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 reports).

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.

• MalfunctionFeb 14, 2020Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE EVALUATOR STATED THAT THEY WERE UNSURE IF THE CATHETER WAS COMFORTABLE FOR THE PATIENT, AS THE CATHETER WAS TOO FLEXIBLE.THEY FELT AS THOUGH THEY HAD TO CRAM IT INTO THE URETHRA.IT WAS DIFFICULT TO INFLATE THE DEVICE. THE DEVICE WOULD NOT INFLATE AND STAY IN PLACE. THE HOSPITAL WAS ABLE TO PUT A SMALL AMOUNT OF WATER INTO THE CATHETER FROM THE SYRINGE PRIOR TO INFLATION.TROUBLESHOOTING WAS PERFORMED AND THE CATHETER WAS REPOSITIONED. THE CATHETER DID NOT MEET ANY RESISTANCE INTERNALLY. THE PATIENT HAD AN EPIDURAL, AND THERE WAS NO OCCLUSION UPON REMOVAL.

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

  MAUDE report 9711874 ↗
• MalfunctionFeb 14, 2020Inflation Problem; Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE EVALUATOR STATED THAT THEY WERE UNSURE IF THE CATHETER WAS COMFORTABLE FOR THE PATIENT, AS THE CATHETER WAS TOO FLEXIBLE. THEY FELT AS THOUGH THEY HAD TO CRAM IT INTO THE URETHRA. IT WAS DIFFICULT TO INFLATE THE DEVICE. THE DEVICE WOULD NOT INFLATE AND STAY IN PLACE. THE HOSPITAL WAS ABLE TO PUT A SMALL AMOUNT OF WATER INTO THE CATHETER FROM THE SYRINGE PRIOR TO INFLATION. TROUBLESHOOTING WAS PERFORMED AND THE CATHETER WAS REPOSITIONED. THE CATHETER DID NOT MEET ANY RESISTANCE INTERNALLY. THE PATIENT HAD AN EPIDURAL AND THERE WAS NO OCCLUSION UPON REMOVAL.

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

  MAUDE report 9711776 ↗