Bardex® Silicone Coated Foley Catheter 0166V14SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741039485), received between Nov 1, 2023 and Jul 17, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025, THE NURSE PERFORMED PREOPERATIVE CATHETERIZATION WITH THE FOLEY CATHETER FOR THE PATIENT, DURING WHICH THE BALLOON INTERFACE FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533095 ↗
• MalfunctionMay 16, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN REPLACING THE CYSTOSTOMY CATHETER, AFTER FILLING THE FOLEY CATHETER BALLOON WITH WATER TO FIX IT, THE BALLOON LEAKED, RESULTING IN REPLACEMENT FAILURE. ANOTHER CATHETER WAS IMMEDIATELY USED FOR REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036254 ↗
• MalfunctionMar 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT BEFORE CHANGING THE FOLEY CATHETER FOR THE PATIENT, THE CATHETER BALLOON WAS TESTED AND IT WAS FOUND THAT FLUSHING WITH WATER OR AIR WAS VERY LABORIOUS, THE JOINT WAS EASILY SUNKEN, AND THE LIQUID OR GAS THAT HAD BEEN INJECTED COULD NOT BE FULLY WITHDRAWN. REPLACING THE SYRINGE AND USING DIFFERENT TYPES OF SYRINGES WERE ALSO VERY LABORIOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676600 ↗
• MalfunctionMar 21, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BEFORE CHANGING THE FOLEY CATHETER FOR THE PATIENT, THE CATHETER BALLOON WAS TESTED AND IT WAS FOUND THAT FLUSHING WITH WATER OR AIR WAS VERY LABORIOUS, THE JOINT WAS EASILY SUNKEN, AND THE LIQUID OR GAS THAT HAD BEEN INJECTED COULD NOT BE FULLY WITHDRAWN. REPLACING THE SYRINGE AND USING DIFFERENT TYPES OF SYRINGES WERE ALSO VERY LABORIOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663196 ↗
• MalfunctionNov 27, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE DOCTOR REPLACED THE CYSTOSTOMY TUBE FOR THE PATIENT, BUT THE FOLEY CATHETER BALLOON FELL OFF WHEN THE FLUID WAS INJECTED. THE DOCTOR REPLACED THE CATHETER AND REPEATED THE OPERATION, BUT THE SAME THING HAPPENED. LOT#MYGN4270 AND LOT#UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797629 ↗
• MalfunctionNov 27, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE DOCTOR REPLACED THE CYSTOSTOMY TUBE FOR THE PATIENT, BUT THE FOLEY CATHETER BALLOON FELL OFF WHEN THE FLUID WAS INJECTED. THE DOCTOR REPLACED THE CATHETER AND REPEATED THE OPERATION, BUT THE SAME THING HAPPENED. LOT #MYGN4270 AND LOT #UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795215 ↗
• MalfunctionOct 30, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2024 AT 09:00, 130 BED NEEDS URINARY FOLEY CATHETER REPLACEMENT AND TESTED WATER BLADDER FOR INTEGRITY DURING INSERTION OF URINARY CATHETER, FOUND THAT GAS COULD NOT BE PUMPED OUT AFTER PUMPING IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566401 ↗
• MalfunctionNov 1, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE NURSE GAVE THE PATIENT A PREOPERATIVE CATHETERIZATION ON SEPTEMBER 2ND, 2023, BEFORE THE OPERATION STARTED. AFTER WASHING THEIR HANDS, THE NURSE TESTED THE CATHETER LEAKAGE AND FOUND THAT THE BALLOON COULD NOT BE WITHDRAWN. THEY REPLACED THE CATHETER IMMEDIATELY. IT WAS IMPOSSIBLE TO PULL OUT THE URINARY CATHETER. AS PER EVENT CAUSE ANALYSIS AND DESCRIPTION, STATED THAT THE WATER INJECTION INTERFACE OF THE URINARY CATHETER SLIPPED INTO THE Y-SHAPED OPENING OF THE URINARY CATHETER, MAKING IT IMPOSSIBLE TO WITHDRAW THE FIXED LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047233 ↗