Bardex® Lubri-Sil® All-Silicone Foley Catheter 175822Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741034190), received between Apr 4, 2024 and Apr 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT STAY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845338 ↗
• MalfunctionApr 4, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROBLEM WITH THE CATHETER WAS THAT IT DID NOT DEFLATE. THE REGISTERED NURSE WHO CHANGED THE CATHETER ALWAYS FOLLOWED PROTOCOL AND TESTED BY FILLING IT FIRST AND THEN DEFLATED IT. THIS WOULD AVOID HAVING INSERTED IT AND THEN NOT BEING ABLE TO REMOVE IT WHEN TIME CALLED FOR CHANGE. IT WOULD HAVE TO BE CUT OUT. CUSTOMER HAD BEEN USING THIS PRODUCT FOR YEARS. THIS WAS THE SECOND TIME CUSTOMER HAD A PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040038 ↗