Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741018220), received between Oct 18, 2022 and Feb 23, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, PATIENT DID NOT AGREE THAT THE BENEFITS OF USING THE BARD/BECTON DICKINSON BIOCATH PRODUCT OUTWEIGH THE POTENTIAL RISKS BECAUSE IT MIGHT GET IN A KNOT IN RELATION TO TIEMANN MODEL, LUBRICATH, 2-WAY, 30CC BALLOON, FRENCH SIZE 24.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428393 ↗
• InjuryOct 18, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FOLEY CATHETER WITH 30 CC BALLOON INSERTED DUE TO STRAIGHT CATHETER UNSUCCESSFUL. ON (B)(6) 2022, THE PATIENT WAS PULLING AT FOLEY AND CAUSING TRAUMA AND DEVELOPED SANG DISCHARGE IN FOLEY. WHEN ATTEMPTED TO REMOVE FOLEY, IT WAS UNABLE TO REMOVE DUE TO BULB NOT DEFLATING. CONFIRMED ON ULTRASOUND THAT BULB WAS FULL WITH FLUID. ATTEMPTED CLIENT REPOSITIONING AND MULTIPLE ATTEMPTS TO WITHDRAW FLUID. SURGICAL CONSULT WAS RECOMMENDED TO HAVE AN ULTRASOUND GUIDED PROCEDURE COMPLETED. ON (B)(6) 2022, THE PATIENT WAS LEFT TO FACILITY 2 FOR SURGICAL CONSULT. BULB WAS DEFLATED AND NEW FOLEY INSERTED. REMOVED WHEN BACK IN FACILITY. INCIDENT WAS THOUGHT TO HAVE OCCURRED DUE TO FAULTY EQUIPMENT AND WAS ABLE TO REMOVE ABOUT 2.5 ML OR LESS OF FLUID, UNABLE TO REMOVE MORE. BULB WAS NOT TESTED/INFLATED PRIOR TO INSERTION. THIS WAS NOT DONE DUE TO RECENT CHANGES TO BEST PRACTICE FOR FOLEY CATHETER INSERTION.

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

  MAUDE report 15626905 ↗
• MalfunctionOct 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD A FOLEY CATHETER WITH 30 CC BALLOON INSERTED DUE TO STRAIGHT CATHETER UNSUCCESSFUL. ON (B)(6) 2022, THE PATIENT WAS PULLING AT FOLEY AND CAUSING TRAUMA AND DEVELOPED SANG DISCHARGE IN FOLEY. WHEN ATTEMPTED TO REMOVE FOLEY, IT WAS UNABLE TO REMOVE DUE TO BULB NOT DEFLATING. CONFIRMED ON ULTRASOUND THAT BULB WAS FULL WITH FLUID. ATTEMPTED CLIENT REPOSITIONING AND MULTIPLE ATTEMPTS TO WITHDRAW FLUID. SURGICAL CONSULT WAS RECOMMENDED TO HAVE AN ULTRASOUND GUIDED PROCEDURE COMPLETED. ON (B)(6) 2022, THE PATIENT WAS LEFT TO FACILITY 2 FOR SURGICAL CONSULT. BULB WAS DEFLATED AND NEW FOLEY INSERTED. REMOVED WHEN BACK IN FACILITY. INCIDENT WAS THOUGHT TO HAVE OCCURRED DUE TO FAULTY EQUIPMENT AND WAS ABLE TO REMOVE ABOUT 2.5 ML OR LESS OF FLUID, UNABLE TO REMOVE MORE. BULB WAS NOT TESTED/INFLATED PRIOR TO INSERTION. THIS WAS NOT DONE DUE TO RECENT CHANGES TO BEST PRACTICE FOR FOLEY CATHETER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624446 ↗