Bardex® Davis Model Foley Catheter 0187LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741019272), received between Mar 14, 2019 and Aug 22, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Degraded” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2019Degraded; Material Split, Cut or Torn; Degraded

  IT WAS REPORTED THAT FOUR FOLEY CATHETERS HAD BALLOONS WITH SLITS IN THEM.

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

  MAUDE report 8922246 ↗
• MalfunctionMar 14, 2019Burst Container or Vessel; Degraded; Appropriate Device Problem Term/Code Not Available; Degraded

  IT WAS REPORTED THAT THE BALLOON BURST. THE UROLOGIST ALLEGED THAT THE CATHETER WAS DRY ROTTED BUT NOT EXPIRED.

  Patient problems: No Information

  MAUDE report 8421531 ↗
• MalfunctionMar 14, 2019Degraded; Product Quality Problem; Degraded

  IT WAS REPORTED THAT THE CATHETER APPEARED TO BE DRY ROTTED BUT HAD NOT EXPIRED.

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

  MAUDE report 8420659 ↗