Bard® Foley Catheter Silicone Coated 265720Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741039614), received between Sep 26, 2017 and Dec 22, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS GETTING CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036154 ↗
• MalfunctionAug 30, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT DUE TO BALLOON BURST. PER CUSTOMER VIA PHONE ON 08OCT2021, IT WAS STATED THAT BARD URINARY DRAIN BAG WAS LEAKING DUE TO PIN HOLE AND HAD ODOR, ALSO THE STEM WAS BROKEN AT THE CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381848 ↗
• MalfunctionAug 26, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BURST AND THE FOLEY CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370132 ↗
• MalfunctionNov 6, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT DEFLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10801308 ↗
• MalfunctionAug 26, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT TWO FOLEY CATHETERS PREMATURELY DEFLATED, FELL OUT AND HAD TO BE DISCARDED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932139 ↗
• MalfunctionFeb 25, 2019Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE SILICONE FOLEY CATHETER WOULD NOT INFUSE WHEN BEING FILLED WITH WATER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8366821 ↗
• MalfunctionSep 25, 2018Material Invagination; Material Integrity Problem; Material Invagination

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER MUSHROOMED WHILE BEING INJECTED WITH WATER.

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

  MAUDE report 7905529 ↗
• MalfunctionAug 17, 2018Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER STOPPED WORKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7793898 ↗
• MalfunctionSep 26, 2017Inflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WOULD NOT INFLATE. THE WATER THAT WAS INSERTED INTO THE BALLOON WAS FOUND LEAKING FROM THE Y-CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6893506 ↗