Bardex® I.C. Foley Catheter 0166SI26Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741016899), received between Apr 13, 2022 and Apr 18, 2022 — classified as 2 malfunctions.

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

• MalfunctionApr 18, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER LOCKED UP AND DID NOT DEFLATE. PER EMAIL FROM CARDINAL HEALTH ON (B)(6) 2022, IT WAS REPORTED THAT THE FOLEY CATHETER WOULD GET STUCK AND WOULD NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137601 ↗
• MalfunctionApr 13, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WOULD NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102878 ↗