SureStep™ Foley Tray System Bard® Lubricath Foley A800364Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741073953), received between Oct 16, 2018 and May 31, 2024 — classified as 3 malfunctions.

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

• MalfunctionMay 31, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE DEFLATED. THE PATIENT EXPERIENCED INCONVENIENCE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 19434079 ↗
• MalfunctionJan 28, 2021Deflation Problem; Difficult to Remove

  UPON COMPLETION OF MEDICATION REGIMEN, AN ATTEMPT WAS MADE TO REMOVE PATIENT'S FOLEY CATHETER. ONLY 6 CC'S WERE ABLE TO BE REMOVED FROM THE FOLEY BALLOON. FOLEY CONTINUES TO FUNCTION AND DRAIN URINE. BALLOON INFLATION LINE CUT, BUT NO AIR WOULD COME OUT OF BALLOON. BALLOON ULTIMATELY PUNCTURED BY PROVIDER AND DEFLATED.

  Patient problems: Insufficient Information

  MAUDE report 11243233 ↗
• MalfunctionOct 16, 2018Leak/Splash

  IT WAS REPORTED THAT THE DEVICE LEAKED. AT THIS TIME IT IS UNKNOWN WHAT COMPONENT OF THE TRAY LEAKED.

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

  MAUDE report 7971483 ↗