Bardex® All-Silicone Foley Catheter 166824Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741029844), received between Feb 24, 2020 and Sep 10, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT BLOW UP. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014942 ↗
• MalfunctionApr 24, 2025Inflation Problem; Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT INFLATE ON ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900341 ↗
• MalfunctionJan 27, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN FOLEY CATHETER WAS USED, IT DID NOT TRANSFER THE LIQUID PROPERLY AND SEEMED PUNCTURED OR BENT WHEN PATIENT TRIED TO USE THE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240067 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION, PAIN, HEMATURIA, EPIDIDYMITIS, URETHRAL TRAUMA, CATHETER BLOCKAGE, LEAKAGE AND ACCIDENTAL REMOVAL WHEN ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Hematuria; Pain; Urinary Tract Infection

  MAUDE report 13970868 ↗
• MalfunctionJun 4, 2020Use of Device Problem; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE HOSPITAL STATED THEY HAD A FOLEY THAT HAD A TORN BALLOON. AS PER ADDITIONAL FOLLOW UP IT WAS REPORTED THAT THEY USE THESE IN LABOR AND DELIVERY AND INFUSED LARGE AMOUNT OF SALINE INTO THE BALLOON FOR THE INDUCTION OF LABOR. THIS COULD HAVE CAUSED THE BALLOON TO TEAR.

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

  MAUDE report 10121377 ↗
• MalfunctionFeb 24, 2020Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY WAS INFLATED WITH 40 CC'S OF STERILE WATER AND BURST. THE FOLEY WAS REPLACED WITHOUT INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745369 ↗