Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0102L12Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741018107), received between May 2, 2017 and Jun 18, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON INSIDE THE PATIENT WOULD NOT DEFLATE, THEY HAD TO POP THE BALLOON FROM THE OUTSIDE PUNCTURED THROUGH THE SKIN.

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

  MAUDE report 22284919 ↗
• MalfunctionJun 16, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER FAILED, IN PATIENT. FOLEY CATHETER HAD TO BE DEFLATED BY PIERCING THROUGH PATIENT'S SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211153 ↗
• MalfunctionApr 26, 2024Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE USER INSERTED A COUDE TIP CATHETER INTO PATIENT. INFLATED BALLOON WITH 10ML NS. PATIENT HAD FELT A "POP". WHEN THE PROCEDURE WAS COMPLETE, THE USER PULLED CATHETER AND THE SILICONE OF WHERE BALLOON WAS HANGING OFF CATHETER TUBING. PATIENT DID NOT HAVE ANY PAIN WITH SAME AND HAD INCONVENIENCE. PER ADDITIONAL INFORMATION RECEIVED ON 08APR2024, IT WAS REPORTED THAT AFTER REMOVING THE CATHETER AFTER IT HAD POPPED, THE SILICONE PIECE WHERE THE BALLOON WAS HAD OBVIOUSLY BROKEN SINCE IT HAD BURST WHILE IN THE PATIENT.

  Patient problems: Discomfort

  MAUDE report 19192642 ↗
• MalfunctionFeb 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER HAD A SAFETY EVENT REPORTED FOR FOLEY CATHETER. THE DEFECTIVE PRODUCT HAD BEEN DISCARDED BY THE CLINICIANS. 12FR RIBBED BALLOON COUDE TIP FOLEY CATHETER HAD A VERY TINY HOLE WHICH CAUSED LEAKAGE OF URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788583 ↗
• MalfunctionJan 23, 2024Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON UTILIZING THE FOLEY CATHETER, THEY HAD OBSERVED RECURRENT INSTANCES OF BREAKAGE OCCURRING AT THE Y-PORT OF THE CATHETER. THIS ISSUE HAD RESULTED IN THE DEFLATION OF THE CATHETER'S BALLOON, SUBSEQUENTLY CAUSING THE CATHETER TO DISLODGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562422 ↗
• MalfunctionMay 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD CRACKS AT Y CONNECTION. THEN THE BALLOON DEFLATES, AND THE CATHETER FALLS OUT. THIS HAD HAPPENED 4 TIMES IN THE LAST FEW MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939200 ↗
• MalfunctionApr 25, 2023Material Invagination; Difficult to Remove; Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED AND BALLOON INFLATED PRIOR TO PROCEDURE WITHOUT DIFFICULTY. POST OPERATIVELY, THE REGISTER NURSE DEFLATED BALLOON TIP WITH EMPTY SYRINGE. WHEN UNABLE TO REMOVE ANY MORE FLUID FROM TIP, REGISTER NURSE ATTEMPTED TO PULL CATHETER OUT BUT RESISTANCE MET CAUSING PATIENT DISCOMFORT. CHARGE REGISTER NURSE TRIED TO TROUBLE SHOOT BY TRYING TO SAW IF ANYMORE FLUID COULD BE REMOVED FROM TIP. NOTHING CAME OUT. FOLEY LEFT IN PLACE. DURING SHIFT, NIGHT REGISTER NURSE AND DAY REGISTER NURSE MADE ANOTHER ATTEMPT TO PULL FOLEY AND THIS TIME IT CAME OUT. TIP OF CATHETER HAD BALLOON STILL SLIGHTLY INFLATED. PATIENT IN STABLE CONDITION WITH NO INJURY.

  Patient problems: Discomfort

  MAUDE report 16806800 ↗
• MalfunctionJan 9, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO AND THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD/BECTON DICKINSON PRODUCT(S) PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCT(S) AND ITS MEDICAL APPLICATION BECAUSE THE INSTRUCTIONS FOR USE (IFU) HAD INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROCESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO CARSON MODEL, LUBRICATH®, 2-WAY, 5CC BALLOON, FRENCH SIZE 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120566 ↗
• MalfunctionJan 4, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE THE INSTRUCTIONS FOR USE (IFU) HAD INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROCESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO CARSON MODEL, LUBRICATH, 2-WAY, 5CC BALLOON, FRENCH SIZE 12.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094969 ↗
• MalfunctionJun 16, 2020Failure to Infuse; Material Rupture; Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER BALLOON RUPTURED WHILE DEPLOYING INTO THE PATIENT URETHRA AND HENCE THE FOLEY WAS REMOVED FROM THE URETHRA. THE SCHEDULED PROCEDURE FOR AN ARTIFICIAL SPHINCTER WAS ABANDONED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE FROM THE FACILITY, THE CATHETER WAS NOT USED ON THE PATIENT. THE COUDE CATHETER WAS TESTED FOR PRE-INFLATION WITH THE STERILE WATER AND THE CATHETER BALLOONED OUT, LIKE AN ANEURYSM ON THE SHAFT OF THE BALLOON. THE ACTUAL CATHETER BALLOON DID NOT BURST. THE PATIENT DID NOT INCURRED ANY INJURY.

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

  MAUDE report 10159432 ↗
• MalfunctionApr 2, 2020Break; Material Puncture/Hole; Break

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE CATHETER.

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

  MAUDE report 9917045 ↗
• MalfunctionMay 9, 2019Inflation Problem; Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE NURSE ATTEMPTED TO INFLATE THE FOLEY CATHETER AFTER IT WAS INSERTED INTO THE PATIENT BUT IT WOULD NOT INFLATE. THE CATHETER WAS REPORTEDLY REMOVED FROM THE PATIENT AND THE NURSE AGAIN ATTEMPTED TO INFLATE THE BALLOON BUT IT REPORTEDLY ONLY INFLATED ALONG ONE SIDE OF THE CATHETER.

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

  MAUDE report 8596314 ↗
• MalfunctionMay 9, 2019Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE NURSE ATTEMPTED TO INFLATE THE FOLEY CATHETER AFTER IT WAS INSERTED INTO THE PATIENT BUT IT WOULD NOT INFLATE. THE CATHETER WAS REPORTEDLY REMOVED FROM THE PATIENT AND THE NURSE AGAIN ATTEMPTED TO INFLATE THE BALLOON BUT IT REPORTEDLY ONLY INFLATED ALONG ONE SIDE OF THE CATHETER.

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

  MAUDE report 8594655 ↗
• MalfunctionJun 4, 2018Difficult to Remove; Aspiration Issue; Difficult to Remove

  IT WAS REPORTED THAT WHILE CATHETERIZING A PATIENT, THE REPORTER CHECKED THE BALLOON PRIOR TO INSERTION AND FOUND THE SOLUTION DID NOT COME BACK OUT OF THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7567321 ↗
• MalfunctionMay 29, 2018Component Falling; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER ALLEGEDLY INFLATED IN THE MIDDLE OF THE SHAFT, AS OPPOSED TO THE TIP. THE CATHETER FELL OUT OF THE PATIENT AFTER 5 MINUTES. A SECOND UNIT WAS USED FOR THE PATIENT.

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

  MAUDE report 7550734 ↗
• MalfunctionMay 24, 2018Inflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WAS INFLATED PRIOR TO PATIENT INSERTION WITH 5ML OF STERILE WATER TO TEST IT. THE USER WAS UNABLE TO WITHDRAW THE WATER FROM THE BALLOON. THEREFORE, THE CATHETER WAS DISCARDED. THIS OCCURRED TWICE WITH TWO CATHETERS OF THE SAME SIZE.

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

  MAUDE report 7542018 ↗
• MalfunctionMay 2, 2017Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BURST. THE COMPLAINANT STATED THAT NO PIECES WERE MISSING, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE COMPLAINANT ALSO STATED THAT THE CATHETER WAS REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 6536585 ↗