Bardex® I.C. Foley Catheter 0167SI18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741017292), received between Nov 11, 2022 and Dec 14, 2022 — classified as 2 injuries.

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 15981229 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED THAT THE INSTRUCTIONS FOR USE (IFU) DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION AS THEY DID NOT AGREE WITH THE STATEMENT SAYING THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCT(S) PROVIDED SUFFICIENT INFORMATION ABOUT THE PRODUCT(S) AND THEIR MEDICAL APPLICATION(S) IN RELATION TO BARDEX I.C. 2 WAY FOLEY CATHETER (STRIP PACK) (FRENCH SIZE 24) AND INFORMED THAT IN THEIR OPINION THE IFU DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT PREVIOUSLY MENTIONED AND ITS MEDICAL APPLICATION BECAUSE OF INADEQUATE OR INSUFFICIENT TRAINING, BARDEX I.C. 2 WAY COUNCIL TIP FOLEY CATHETER (STRIP PACK) NO FRENCH SIZE SPECIFIED AND INFORMED THAT IN THEIR OPINION THE IFU DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT PREVIOUSLY MENTIONED AND ITS MEDICAL APPLICATION BECAUSE OF MISSING INFORMATION ALSO STATED THAT THEY WAS NOT ABLE TO SUCCESSFULLY ACHIEVE HEMOSTASIS WHILE USING THE LARGE 30CC BALLOON BECAUSE OF NEOPLASTIC BLEEDING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15779263 ↗