Bard® Foley Catheter Silicone Coated 265716Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741039591), received between Sep 25, 2017 and Jul 20, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD TO CHANGE THE FOLEY AFTER 2 DAYS OF LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358112 ↗
• MalfunctionDec 28, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE CUSTOMER WAS TRYING TO USE A SILICONE ELASTOMER FOLEY CATHETER, AND THE INFLATION PORT CAME OFF WHILE TRYING TO INFLATE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060683 ↗
• MalfunctionMay 11, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT SOME OF THE FOLEY CATHETER BALLOONS BURST ON THE PATIENT AND IT WAS TIME TO CHANGE THE CATHETER, BUT THE PATIENT DID NOT EVEN BOTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14355688 ↗
• MalfunctionNov 24, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON GOT DEFLATED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868917 ↗
• MalfunctionAug 5, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE UROLOGIST WAS UNABLE TO DEFLATE THE BALLOON IN ORDER TO EXTRACT IT FROM THE FOOT. THE UROLOGIST SAID THE PATIENT NEVER WANTED TO USE BARD BRAND CATHETERS AGAIN. THE UROLOGIST KEPT THE OTHER CATHETER ON HAND, SO, THE PATIENT COULD NOT USED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283126 ↗
• MalfunctionApr 1, 2020Partial Blockage; Complete Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETER WAS CLOGGED, AND HE HAD TO CHANGE IT AHEAD OF SCHEDULE.

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

  MAUDE report 9914016 ↗
• MalfunctionMar 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE 5CC BALLOON WAS TOO SMALL. THE PATIENT EXPERIENCED LEAKAGE FROM THE MEATUS DUE TO THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832818 ↗
• MalfunctionFeb 20, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE SILICONE FOLEY CATHETER EXPLODED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PER NEW INFORMATION RECEIVED; IT WAS REPORTED THAT THE BALLOON OF THE SILICONE FOLEY CATHETER BURST. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732836 ↗
• MalfunctionFeb 18, 2020Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT PASSIVELY DEFLATE WITH THE SYRINGE. THE COMPLAINANT REPORTED THAT THE USER THEN TRIED TO PULL BACK ON THE SYRINGE BUT THAT WOULD NOT WORK EITHER. THE CATHETER WAS ULTIMATELY CUT AND THE BALLOON GOT DEFLATED.

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

  MAUDE report 9721018 ↗
• MalfunctionFeb 13, 2020Break; Material Puncture/Hole; Break

  IT WAS REPORTED THAT THE PATIENT STATED THE NURSE WAS INSERTING HIS LAST FOLEY CATHETER, AND SHE FOUND A HOLE IN THE BALLOON AND COULD NOT USE IT. THE NURSE HAD AN EXTRA FOLEY ON HER WHICH THEY USED.

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

  MAUDE report 9708152 ↗
• InjuryFeb 26, 2019Break; Burst Container or Vessel; Entrapment of Device; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE SILICONE FOLEY CATHETER BURST INSIDE OF THE PATIENT'S BLADDER. PATIENT REQUIRED SURGERY TO REMOVE THE MISSING PIECES.

  Patient problems: Foreign Body In Patient

  MAUDE report 8371903 ↗
• MalfunctionSep 25, 2017Incorrect Measurement; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS APPEARED TO BE THE INCORRECT SIZE.

  Patient problems: No Information

  MAUDE report 6890805 ↗