Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0102L14Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741018114), received between Jan 10, 2018 and Jul 10, 2025 — classified as 4 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (8 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE HOSPITAL USER INSERTED CATHETER AND INFLATED BALLOON WITH 10 MLS STERILE WATER. AFTER A FEW MINUTES OF LETTING THE BLADDER DRAIN, HOSPITAL USER NOTICED THAT THE GREEN TIP WHERE STERILE WATER WAS INSTILLED HAD FALLEN OFF AND THE STERILE WATER DRAINED OUT. HOSPITAL USER CALLED COWORKER TO LOOK AT CATHETER AND TO BRING ANOTHER CATHETER TO REINSERT. FORTUNATELY, PATIENT TOLERATED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467902 ↗
• MalfunctionDec 30, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER TO BE INSERTED WHEN GATHERING SUPPLIES NURSE NOTED TIP OF CATHETER BLUNTED OR CUT. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED ON 20DEC2024, IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT, AND THE CATHETER WAS NOT USED JUST IDENTIFIED IT WAS MISSING THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035167 ↗
• MalfunctionJul 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT WAS TO RECEIVE GEMZARD TREATMENT AND A FOLEY CATHETER WAS INSERTED TO THE PATIENT BY A NURSE. TREATMENT WAS ADMINISTERED, WELL TOLERATED, AND UPON TRYING TO REMOVE THE STERILE WATER FROM THE CATHETER BALLOON, IT COULD NOT BE DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691099 ↗
• MalfunctionJun 20, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE STAFF WHO INITIALLY DID GEM TREATMENT WAS ON BREAK. THE USER UNCLAMPED THE CATHETER TUBING TO ALLOW IT TO DRAIN. WHEN THE USER WENT BACK IN TO INSTALL DOCETAXEL, THE USER NOTICED THE PATIENT¿S BED WAS ALL WET. PATIENT STATED THAT THEY THOUGHT THEY WERE SWEATING. WHEN INSTILLING DOCETAXEL, FLUID WAS NOTED TO BE DRAINING OUT THE CATHETER TUBING CLOSE TO THE HUB. A WATERPROOF TAPE WAS APPLIED TO THE SAME AND HELD WITH HAND TO FINISH INSTILLING DOCETAXEL. THE CO-STAFF MEMBER ASSISTED TO DEFLATE THE BALLOON AND THE CATHETER WAS REMOVED. THE PATIENT WAS CLEANED UP WITH SOAP AND WATER AS PER THE POLICY AND PROTOCOL. BEDDING WAS PLACED IN A PROPER RED BIOHAZARD BIN AND THE BED WAS CLEANED WITH BLEACH BY FELLOW STAFF MEMBERS. THE PATIENT EXPERIENCED INCONVENIENCE.

  Patient problems: Discomfort

  MAUDE report 19574106 ↗
• MalfunctionApr 15, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE USER NOTICED THE BED TO BE WET POST GEMCITABINE INSTALLMENT BY OTHER STAFF MEMBER. THERE WAS A HOLE NOTED ON THE CATHETER TUBING WHERE THE TREATMENT WAS SLOWLY DRAINING FROM. THE PATIENT EXPERIENCED INCONVENIENCE. PER SAMPLE RETURNED NOTIFICATION RECEIVED FROM THE INVESTIGATOR ON 16APR2024, THE CUSTOMER RETURNED A 165814 CATHETER.

  Patient problems: Discomfort

  MAUDE report 19106402 ↗
• MalfunctionApr 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT CUSTOMER HAD IDENTIFIED A DEFECTIVE BARD PRODUCT. FOLEY CATHETER HAD A SMALL HOLE AT THE TOP OF THE PORT WHERE THE SYRINGE WAS INSERTED. WHEN TRYING TO INFLATE THE BALLOON, THE SALINE SPRAYED OUT OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019105 ↗
• MalfunctionNov 9, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON ASSUMED TO BE LOSING FLUID SINCE INSERTION IN OPERATION ROOM. BEDSIDE NURSE NOTED THAT THE CATHETER WAS COMING OUT OF PATIENT. EMPTIED FLUID IN BALLOON AND NOTED ONLY 1 CC OF FLUID WAS ABLE TO BE REMOVED. NORMAL BALLOON HAD 30+CC OF FLUID INSTILLED ORIGINALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104492 ↗
• MalfunctionAug 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DAMAGED.

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

  MAUDE report 17652590 ↗
• MalfunctionAug 2, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT NURSE WENT TO INSERT A FOLEY CATHETER AND THE BALLOON KEPT DEFLATING. THEY FOUND THE GREEN PORT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442291 ↗
• MalfunctionJan 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER PLACED BY LICENSED PRACTICAL NURSE (LPN), NO URINE RETURNED AND UNABLE TO IRRIGATE ANY STERILE SALINE INTO CATHETER. STATED THAT THE CATHETER REMOVED FROM THE PATIENT, STILL UNABLE TO IRRIGATE SALINE THROUGH CATHETER. UPON INSPECTION, END OF CATHETER DID NOT HAVE HOLES TO ALLOW URINE TO DRAIN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216607 ↗
• MalfunctionJan 19, 2023Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE FOLEY CATHETER PLACED BY A LICENSED PRACTICAL NURSE (LPN), NO URINE RETURNED AND UNABLE TO IRRIGATE ANY STERILE SALINE INTO CATHETER. STATED THAT THE CATHETER REMOVED FROM THE PATIENT, STILL UNABLE TO IRRIGATE SALINE THROUGH CATHETER. UPON INSPECTION, THE END OF THE CATHETER DID NOT HAVE HOLES TO ALLOW URINE TO DRAIN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206800 ↗
• 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 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120570 ↗
• MalfunctionJan 4, 2023Inadequate Instructions for Healthcare Professional; Inadequate or Insufficient Training; Inadequate Instructions for Healthcare Professional; 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 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094967 ↗
• MalfunctionJan 3, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE INDWELLING CATHETER AND CHANGED IT EVERY TWO MONTHS. IT WAS STATED THAT CUSTOMER FLUSHES THE CATHETER ONCE A DAY AND USUALLY AT NIGHT. ON 12/15 WHEN CUSTOMER TRIED TO FLUSH THEY COULD NOT DO IT AND WAS LIKE THE CATHETER WAS BLOCKED OR CLOGGED. SO THEY TRIED CHANGING BALLOON AND SEVERAL THINGS BUT NOTHING WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16088368 ↗
• MalfunctionSep 14, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS A DEFLATION PROBLEM, DEVICE DISLODGED OR DISLOCATED. ALLEGEDLY PATIENT HAD URINARY RETENTION, DEPRESSION, DISCOMFORT AND PAIN. IT WAS FURTHER REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 21DEC2020, IT WAS EVALUATED THAT THE DISLODGEMENT IS A CASCADING EVENT AS A RESULT OF DEFLATION. PER ADDITIONAL INFORMATION VIA EMAIL FROM CANADA TEAM ON 30AUG2022, STATED THAT PATIENT'S LONG-TERM INDWELLING FOLEY CATHETER BECAME DISLODGED, ATTEMPTED TO RE-INSERT WERE UNSUCCESSFUL. THE PATIENT WAS HOSPITALIZED, AND INSERTION OF THE CATHETER WAS DONE. A 14 FR COUDE TIP CATHETER WAS INSERTED, BUT STILL NO URINE DRAINING. ATTEMPTS WERE MADE TO REMOVE THE INSERTED FOLEY BUT UNSUCCESSFUL DESPITE TRYING TO DEFLATE THE BALLOON AS WELL AS CUTTING THE BALLOON PART OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418372 ↗
• MalfunctionSep 13, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THERE WAS A DEFLATION PROBLEM, DEVICE DISLODGED OR DISLOCATED. ALLEGEDLY PATIENT HAD URINARY RETENTION, DEPRESSION AND DISCOMFORT. IT WAS FURTHER REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED. AS PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2020, IT WAS EVALUATED THAT THE DISLODGEMENT IS A CASCADING EVENT AS A RESULT OF DEFLATION. AS PER ADDITIONAL INFORMATION VIA EMAIL FROM CANADA TEAM ON (B)(6) 2022, STATED THAT PATIENTS LONG-TERM INDWELLING FOLEY CATHETER BECAME DISLODGED, ATTEMPTED TO RE-INSERT WERE UNSUCCESSFUL. PATIENT WAS HOSPITALIZED AND INSERTION OF CATHETER WAS DONE. A 14 FR COUDE TIP CATHETER WAS INSERTED BUT STILL NO URINE DRAINING . ATTEMPTS WERE MADE TO REMOVE THE INSERTED FOLEY BUT UNSUCCESSFUL DESPITE TRYING TO DEFLATE THE BALLOON AS WELL AS CUTTING THE BALLOON PART OFF .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410352 ↗
• MalfunctionMay 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHEN NURSE STARTED TO INFLATE THE FOLEY CATHETER BALLOON AFTER PLACED A 14 FRENCH COUDE FOLEY CATHETER, SALINE STARTED SPRAYING EVERYWHERE. IT APPEARED THERE WAS A HOLE WHERE THE SALINE SYRINGE LOCKED INTO FOLEY AND WAS LEAKING FROM THERE. THE FOLEY CATHETER WAS REMOVED AND REPLACED WITH A DIFFERENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548323 ↗
• MalfunctionMar 8, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE COUDE TIP FOLEY CATHETER WAS MISSING WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698325 ↗
• MalfunctionMar 8, 2022Component Misassembled; Material Split, Cut or Torn; Component Misassembled; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF THE FOLEY CATHETER WAS MISSING WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697835 ↗
• InjuryAug 10, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD A DEFLATION PROBLEM. THE PATIENT EXPERIENCED DEPRESSION URINARY RETENTION DISCOMFORT AND NEEDED UNEXPECTED MEDICAL INTERVENTION MEDICAL ASSESSMENT WAS PENDING. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Depression; Discomfort; Urinary Retention

  MAUDE report 12305099 ↗
• InjuryJun 9, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE REGARDING A 14FR COUDE FOLEY THAT WAS UNABLE TO DEFLATE. THEY ENDED UP HAVING TO CUT THE ONE-WAY VALVE TO DEFLATE THE BALLOON. THE PATIENT DID NOT SUFFER ANY ILL EFFECTS AND THE PACKAGE OF THE FOLEY WAS DISCARDED. PER ADDITIONAL INFORMATION RECEIVED ON 14JAN2021, IT WAS REPORTED THAT AGAIN A 14 FRENCH COUDE WAS UNABLE TO DEFLATE THE BALLOON. THE USER HAD TO CUT THE VALVE BUT THAT DID NOT WORK. THE PATIENT HAD TO GO TO RESEARCH WAY TO HAVE IT DEFLATED. THE UROLOGIST PASSED A WIRE THROUGH THE FOLEY AND DEFLATED THE BALLOON. THE UROLOGIST SAID THAT THERE WAS A MANUFACTURING DEFECT ABOUT HALF WAY UP THE CATHETER. ALSO, THE CUSTOMER HAD 6 ADDITIONAL UNUSED CATHETERS FROM THE CANCER CENTER. THE PATIENT HAD TO LEAVE THE CANCER CENTER AND WAS TAKEN TO THE CLINIC FOR REMOVAL. PER FOLLOW UP RESPONSE RECEIVED ON 20JAN2021, THE PATIENT¿S TREATMENT WAS DELAYED, AND THE PATIENT WAS NOT HARMED DUE TO EXCELLENCE IN CARE AND RESCUE EFFORTS. THE PATIENT WAS INCONVENIENCED AND NEED TO BE TRANSFERRED OFF SITE TO ONE OF OUR CLINICS TO HAVE THE CATHETER REMOVED, AND ADDITIONAL COSTS WERE INCURRED BY THE FACILITY. PER ADDITIONAL FORMATION RECEIVED ON 17MAY2021, STA

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

  MAUDE report 11971583 ↗
• InjuryFeb 8, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE REGARDING A 14FR COUDE FOLEY THAT WAS UNABLE TO DEFLATE. THEY ENDED UP HAVING TO CUT THE ONE-WAY VALVE TO DEFLATE THE BALLOON. THE PATIENT DID NOT SUFFER ANY ILL EFFECTS AND THE PACKAGE AND FOLEY WERE DISCARDED. PER ADDITIONAL INFORMATION RECEIVED ON 14JAN2021, IT WAS REPORTED THAT AGAIN A 14 FRENCH COUDE WAS UNABLE TO DEFLATE THE BALLOON. THE USER HAD TO CUT THE VALVE BUT THAT DID NOT WORK. THE PATIENT HAD TO GO TO RESEARCH WAY TO HAVE IT DEFLATED. THE UROLOGIST PASSED A WIRE THROUGH THE FOLEY AND DEFLATED THE BALLOON. THE UROLOGIST SAID THAT THERE WAS A MANUFACTURING DEFECT ABOUT HALFWAY UP THE CATHETER. ALSO, THE CUSTOMER HAD 6 ADDITIONAL UNUSED CATHETERS FROM THE CANCER CENTER. THE PATIENT HAD TO LEAVE THE CANCER CENTER AND BE TAKEN TO THE CLINIC FOR REMOVAL. PER FOLLOW UP RESPONSE RECEIVED ON 20JAN2021, THE PATIENT¿S TREATMENT WAS DELAYED, AND THE PATIENT WAS NOT HARMED DUE TO EXCELLENCE IN CARE AND RESCUE EFFORTS. THE PATIENT WAS INCONVENIENCED AND NEEDED TO BE TRANSFERRED OFF SITE TO ONE OF OUR CLINICS TO HAVE THE CATHETER REMOVED, AND ADDITIONAL COSTS WERE INCURRED BY THE FACILITY. PER ADDITIONAL FORMATION RECEIVED ON 17MAY2021, STATE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11297631 ↗
• InjuryDec 23, 2020Decrease in Pressure; Device Dislodged or Dislocated; Decrease in Pressure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A DEFLATION PROBLEM, DEVICE DISLODGED OR DISLOCATED. ALLEGEDLY PATIENT HAD URINARY RETENTION, DEPRESSION AND DISCOMFORT. IT WAS FURTHER REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 21DEC2020, IT WAS EVALUATED THAT THE DISLODGEMEMT IS A CASCADING EVENT AS A RESULT OF DEFLATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discomfort; Pain; Urinary Retention

  MAUDE report 11065540 ↗
• MalfunctionDec 9, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE WITH SALINE IN THE CATHETER. PER FOLLOW UP VIA PHONE ON 17NOV2020, THE CATHETER INFLATED WITH 10CC, BUT THE BALLOON WOULD NOT INFLATE. THE CATHETER WAS REMOVED AND REPLACED. THE CUSTOMER NOTED THAT THE CATHETER INFLATED WITH THE STERILE WATER, BUT NOT WITH THE SALINE. ALSO, THE CATHETERS CHANGED COLOR TO WHITE AFTER A WEEK OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10978860 ↗
• MalfunctionAug 29, 2020Deflation Problem; Material Puncture/Hole; Device Dislodged or Dislocated; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER BECAME DISLODGED AND UPON INSPECTION, THE BALLOON HAD DEFLATED DUE TO A SMALL PUNCTURE OR PERFORATION ABOVE THE BIFURCATION. PER FOLLOW-UP ON (B)(6) 2020, THE CATHETER WAS USED DRUING A SIMULATION.

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

  MAUDE report 10469705 ↗