Bardex® I.C. Tiemann Model Coude Tip Foley Catheter 0102SI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741017070), received between Oct 8, 2019 and Jul 17, 2025 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT ON 2 SEPARATE OCCASIONS, WHILE REGISTERED NURSE WAS PREPARING FOR FOLEY CATHETER INSERTION AND CONFIRMING THAT THE BALLOON WILL INFLATE AND DEFLATE WITH 10 ML NS, THE BALLOON INFLATES HOWEVER DOES NOT DEFLATE. IT APPEARED POSSIBLE CONCERN WITH THE VALVE FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531709 ↗
• MalfunctionAug 12, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH THE FOLEY CATHETER BALLOON NOT STAYING INFLATED AND HAD TO INFLATE AGAIN EVERY 12 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967181 ↗
• MalfunctionFeb 15, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE HAVE BEEN MULTIPLE ISSUES WITH THIS PRODUCT OVER THE LAST COUPLE OF WEEKS. URINARY FOLEY CATHETER BALLOON DEFLATION MALFUNCTION. TESTED BALLOON PRIOR TO FOLEY INSERTION AND BALLOON DEFLATED PROPERLY. WENT TO DISCONTINUE FOLEY AFTER TREATMENT, AND BALLOON WOULD NOT DEFLATE. ENDED UP CUTTING LINE WITH STERILE SCISSORS AND SALINE EMPTIED AND FOLEY WAS SAFELY REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711051 ↗
• InjuryJan 16, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE FOLEY CATHETERS CAUSED SLIGHT PAIN AND DISCOMFORT, AND NOW THE PATIENT EXPERIENCED BLADDER SPASMS AFTER USING THIS PRODUCT. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA PHONE 05JAN2022, IT WAS REPORTED THAT THE PATIENT GOT A URINARY TRACT INFECTION WHILE USING THE CATHETER AND DOCTOR PRESCRIBED AN ANTIBIOTIC FOR A WEEK. IT WAS ALSO STATED THAT THEY WERE WAITING FOR A NEW CATHETER TO COME IN.

  Patient problems: Urinary Tract Infection

  MAUDE report 13262877 ↗
• MalfunctionJun 30, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT WHILE INSERTING THE FOLEY CATHETER INTO THE PATIENT THAT THE CATHETER CRACKED, THE BALLOON DEFLATED AND THEN THE CATHETER FELL OUT OF THE PATIENT. NO PATIENT INJURY AND MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP RECEIVED ON (B)(6)2021,THE CATHETER WAS CRACKED ON THE SHAFT AND THERE WAS NO PATIENT IMPACT OR MISSING PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093566 ↗
• MalfunctionJun 29, 2021Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE INSERTING THE FOLEY CATHETER INTO THE PATIENT THAT THE CATHETER CRACKED, THE BALLOON DEFLATED AND THEN THE CATHETER FELL OUT OF THE PATIENT. PER FOLLOW UP RECEIVED ON 08JUN2021, THE CATHETER WAS CRACKED ON THE SHAFT AND THERE WAS NO PATIENT IMPACT OR MISSING PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085206 ↗
• MalfunctionOct 8, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE FOLEY CATHETER BEGAN LEAKING. THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS.

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

  MAUDE report 9169112 ↗