Bardex® I.C. Foley Catheter 0167SI20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741017308), received between Jun 25, 2019 and Dec 14, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT WAS ASKED WHETHER THEY BELIEVE THE BENEFITS OF USING THE PRODUCT OUTWEIGH THE POTENTIAL RISKS IN RELATION TO THE BARDEX I.C. 3-WAY IRRIGATION FOLEY CATHETER AS PART OF A CUSTOMER SURVEY. THE RESPONDENT INDICATED THAT NO, THE BENEFITS OF USING THIS PRODUCT DO NOT OUTWEIGH THE POTENTIAL RISKS. WHEN ASKED TO ELABORATE, THE RESPONDENT STATED URETHRAL INJURY. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URETHRAL INJURY (0167SI16, 0167SI18, 0167SI20, 0167SI22, 0167SI24, 0167SI26).

  Patient problems: Tissue Breakdown

  MAUDE report 15980701 ↗
• MalfunctionJun 25, 2019Break; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A SPLIT DOWN THE LENGTH OF THE CATHETER.

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

  MAUDE report 8731658 ↗