Bard® Foley Catheter Silicone Coated 265714Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741039584), received between Nov 13, 2017 and May 3, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2024Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER TIP BROKE OFF WHEN THE PATIENT PULLED THE CATHETER. STATED THAT THE PATIENT WAS ADMITTED INTO THIS FACILITY WITH THE CATHETER INSTALLED AND THE PATIENT HAD TO BE SENT BACK TO THE ACUTE CARE HOSPITAL TO HAVE THE TIP REMOVED, PATIENT WAS CURRENTLY IN THAT HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 19238863 ↗
• InjurySep 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THERE WAS AN ALLEGED POTENTIAL FOR DEATH; HOWEVER, THE ACTUAL ISSUE IS UNKNOWN. PULLED FROM HEALTH CANADA¿S MEDICAL DEVICES ONLINE DATABASES. PER FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2022, FOLEY CATHETER DID NOT DRAIN FOR 6-HOURS AND URINE WAS NOTED TO BE BYPASSING. THE USER ATTEMPTED TO DEFLATE BALLOON TO REMOVE FROM BLADDER WHICH WAS UNABLE TO DO SO . THE CATHETER CLAMPED TO DETACH WHEN BALLOON POPPED INSIDE BLADDER AND THE PATIENT FELT PAIN. CATHETER WAS REMOVED WITH PIECE OF SILICONE THAT MADE UP BALLOON MISSING. CYSTOSCOPY HAD BEEN ORDERED IN ORDER TO REMOVE PIECE OF SILICONE FROM PATIENT'S BLADDER TO PREVENT SEPSIS.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 15461639 ↗
• MalfunctionSep 15, 2022Difficult to Remove; Component Misassembled; Difficult to Remove; Component Misassembled

  IT WAS REPORTED THAT THERE WAS AN ALLEGED POTENTIAL FOR DEATH; HOWEVER, THE ACTUAL ISSUE IS UNKNOWN. PULLED FROM HEALTH CANADA¿S MEDICAL DEVICES ONLINE DATABASES. AS PER FOLLOW-UP INFORMATION RECEIVED ON 30AUG2022, FOLEY CATHETER DID NOT DRAIN FOR 6HOURS AND URINE WAS NOTED TO BE BYPASSING. THE USER ATTEMPTED TO DEFLATE BALLOON TO REMOVE FROM BLADDER WHICH WAS UNABLE TO DO SO. THE CATHETER CLAMPED TO DETACH WHEN BALLOON POPPED INSIDE BLADDER AND THE PATIENT FELT PAIN . CATHETER WAS REMOVED WITH PIECE OF SILICONE THAT MADE UP BALLOON MISSING. CYSTOSCOPY HAD BEEN ORDERED IN ORDER TO REMOVE PIECE OF SILICONE FROM PATIENT'S BLADDER TO PREVENT SEPSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427744 ↗
• MalfunctionSep 13, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THERE WAS AN ALLEGED POTENTIAL FOR DEATH; HOWEVER, THE ACTUAL ISSUE IS UNKNOWN. PULLED FROM HEALTH CANADA¿S MEDICAL DEVICES ONLINE DATABASES . AS PER FOLLOW-UP INFORMATION RECEIVED ON 30AUG2022, FOLEY CATHETER DID NOT DRAIN FOR 6HOURS, AND URINE WAS NOTED TO BE BYPASSING . THE USER ATTEMPTED TO DEFLATE BALLOON TO REMOVE FROM BLADDER WHICH WAS UNABLE TO DO SO. THE CATHETER CLAMPED TO DETACH WHEN BALLOON POPPED INSIDE BLADDER AND THE PATIENT FELT PAIN . CATHETER WAS REMOVED WITH PIECE OF SILICONE THAT MADE UP BALLOON MISSING. CYSTOSCOPY HAD BEEN ORDERED TO REMOVE PIECE OF SILICONE FROM PATIENT'S BLADDER TO PREVENT SEPSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410134 ↗
• MalfunctionJan 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE OF THE FOLEY CATHETERS LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11127115 ↗
• MalfunctionMay 7, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER BECAME CLOGGED CAUSING IT TO NOT DRAIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8589207 ↗
• MalfunctionNov 13, 2017Deflation Problem

  IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO DEFLATE THE FOLEY CATHETER BUT WAS UNSUCCESSFUL. THE PATIENT ALLEGEDLY ATTEMPTED TO PULL OUT THE CATHETER AND EXPERIENCED PAIN. THE PATIENT VISITED THE HOSPITAL WHERE THE FOLEY CATHETER WAS ABLE TO BE SUCCESSFULLY DEFLATED AND REPLACED. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 7024836 ↗