Bardex® Lubricath® Foley Catheter 0119L20Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741019074), received between Mar 5, 2018 and Sep 3, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Material Puncture/Hole

  It was reported that RN at bedside to change CBI (continuous bladder infusion) bags, foley bag was empty, patient reported discomfort/pressure at insertion site. When blanket was lifted to assess foley again it had already slipped out balloon was not inflated out noted small blood clot.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50578068 ↗
• MalfunctionAug 26, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452737 ↗
• MalfunctionMay 1, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED DURING USE AND WAS EXPELLED NATURALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062158 ↗
• MalfunctionApr 15, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD SPONTANEOUS REMOVAL AS THERE WAS A HOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889511 ↗
• MalfunctionDec 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT IN THE NEXT DAY AFTER PLACEMENT IT WAS DISCOVERED FOLEY CATHETER FELL OUT IN THE WARD DUE TO THE BALLOON PORTION WAS TORN. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23DEC2025, STATED THAT CATHETER WAS LEFT IN PLACE AFTER PROSTATE RESECTION. PRESSURE HEMOSTASIS WAS PERFORMED WHILE THE FOLEY CATHETER REMAINED INSERTED. THEREFORE, HAND WAS LISTED AS A POTENTIAL SOURCE OF CONTACT. PRESSURE HEMOSTASIS MIGHT HAVE LED TO BALLOON RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822277 ↗
• MalfunctionNov 24, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER TRANSURETHRAL BLADDER SURGERY, THE DOCTOR INSERTED AND PERFORMED BLADDER IRRIGATION, THEN CONNECTED TO UROGUARD. AFTER THE ANESTHESIOLOGY PROCEDURE, IT WAS CONFIRMED THAT THE FOLEY CATHETER HAD BEEN SPONTANEOUSLY REMOVED. CHECKED FOR LEAKAGE OF STERILE WATER. LEAKAGE OF STERILE WATER WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633734 ↗
• MalfunctionJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WERE THREE CASES OF IMMEDIATE ATROPHIC EVENTS OF FOLEY CATHETER WAS SPONTANEOUSLY EXTRACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167468 ↗
• MalfunctionMay 21, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON DAMAGE WAS DISCOVERED DURING PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061990 ↗
• MalfunctionApr 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER PLACEMENT, THE FOLEY CATHETER WAS NATURALLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899625 ↗
• InjuryFeb 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER ON THE DAY AFTER THE OPERATION, HAD NO URINE IN THE BAG AND WHEN CHECKED, THE CATHETER WAS NO LONGER FALLING OUT. WHEN THE CATHETER WAS CHECKED, THE BALLOON PART WAS MISSING. A 2-WAY CATHETER WAS THEN REINSERTED. SINCE THERE WAS NO PRE-TEST WHEN THE CATHETER WAS INSERTED, IT WAS NOT POSSIBLE TO DO IT FROM THE BEGINNING. SINCE THE PATIENT HAD SURGERY ON THE BLADDER AND HAD JUST BEEN PERFORMED, A CYSTOSCOPE WAS INSERTED TO CONFIRM THE RESIDUAL PRESENCE OF THE BALLOON. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 21JAN2025, THE FIXED WATER WAS 10 ML AND THERE WAS NO TRACTION, CATE JELLY WAS USED. CHECKED WITH THE DOCTOR WHO INSERTED IT, THE PROCEDURE WAS CARRIED OUT AS USUAL AND THE PATIENT INSERTED IT TO THE END, INSERTED 10 CC OF FIXATION WATER, THEN WITHDREW IT SMOOTHLY AND CONSIDERED IT FINISHED BECAUSE FELT IT HAD STOPPED. THERE WAS NO DISCOMFORT. THE REINSERTED BALUN WAS REMOVED ON 21:21. SUBSEQUENT SELF-URINATION WAS UNEVENTFUL, AND NO FOREIGN BODY EJECTION HAS BEEN OBSERVED. THE PATIENT IS IN GOOD GENERAL CONDITION AND WILL BE DISCHARGED HOME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 21332362 ↗
• MalfunctionNov 5, 2024Inflation Problem; Inability to Irrigate; Inflation Problem; Inability to Irrigate

  IT WAS REPORTED THAT THE CATHETER WAS BLOCKED, OR THE FLUID COULD NOT BE INJECTED INTO THE FOLEY CATHETER. PER ADDITIONAL INFORMATION RECEIVED ON 22OCT2024, IT WAS REPORTED THAT THE DURING PLACEMENT ON THE NIGHT OF THE (B)(6), THEY PLACED THE 1243T20 FOR BLADDER IRRIGATION, CONNECTED AN INFUSION LINE TO THE IRRIGATION LUMEN, AND ATTEMPTED TO REFLUX SALINE. THE NEXT MORNING (B)(6), THEY DISCOVERED THAT NOT A SINGLE DROP HAD FLOWED INTO THE IRRIGATION LUMEN. THEY TOOK ANOTHER SIMILAR PRODUCT FROM THE SAME BOX, REPLACED THE CATHETER, CONNECTED AN INFUSION LINE TO THE IRRIGATION LUMEN, AND ATTEMPTED TO REFLUX SALINE, AND WERE ABLE TO PERFORM BLADDER IRRIGATION WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610903 ↗
• MalfunctionSep 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON CUFF BURST AND WAS REMOVED NATURALLY ON THE SAME DAY AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223538 ↗
• MalfunctionJul 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT SOON AFTER INSERTION (THE EXACT PLACEMENT TIME WAS STILL BEING CONFIRMED), AND IN THE DIRECTOR'S CASE, THREE CONSECUTIVE CASES IN THE SAME PATIENT (20FR X 2, 18FR X 1), A STONE HAS COME OUT AND SAID THAT THE CUFF SHOULD NOT BE DAMAGED BECAUSE OF THAT, AND HAVE HAD MAJOR TROUBLE WITH THIS DIRECTOR'S CASE IN THE PAST DUE TO A BALLOON MALFUNCTION . PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16JUL2024, IT WAS REPORTED THAT THE DAMAGE TO THE CUFF WHICH WAS VISIBLE TO THE NAKED EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791954 ↗
• MalfunctionJul 19, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT SOON AFTER INSERTION (THE EXACT PLACEMENT TIME WAS STILL BEING CONFIRMED), AND IN THE DIRECTORS CASE, THREE CONSECUTIVE CASES IN THE SAME PATIENT (20FR , 18FR ) A STONE HAS COME OUT AND SAID THAT THE CUFF SHOULD NOT BE DAMAGED BECAUSE OF THAT, AND HAVE HAD MAJOR TROUBLE WITH THIS DIRECTOR IN THE PAST DUE TO A BALLOON MALFUNCTION NEED TO BE CAREFUL. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16JUL2024, IT WAS REPORTED THAT THE DAMAGE TO THE CUFF WHICH WAS VISIBLE TO THE NAKED EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781810 ↗
• MalfunctionApr 27, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LAST TIME THIS OCCURRED THE FOLEY BALLOON WAS OVER INFLATED, AS TOO LARGE A SYRINGE WAS USED CAUSING EXTRA PRESSURE, THIS HAPPENED THREE TIMES ON THE SAME PATIENT. IT WAS A DUAL LUMEN FOLEY FOR IRRIGATION AND IT WAS A YELLOW RUBBER MATERIAL, NOT SILICONE LIKE MOST OF THEIR FOLEY CATHETERS. A 10ML SYRINGE WAS USED BUT ONLY 6 ML STERILE WATER WAS DRAWN UP IN THE SYRINGE. THE FIRST CATHETER HELD WATER ON TEST BUT RUPTURED ON USE BUT HAD ONLY BEEN INFLATED WITH APPROXIMATELY 3ML OF WATER WHEN IT RUPTURED. THE SECOND FOLEY BALLOON RUPTURED WHEN TESTED AND SOME PRESSURE WAS APPLIED BEFORE USING ON THE PATIENT. THE THIRD FOLEY BALLOON WAS INSPECTED VISUALLY AND DUE TO LOOKING CRACKED OR DRY-ROTTED WAS NOT EVEN TESTED BASED ON THE OTHER FAILURES. THE PACKAGING FOR THE PRODUCT INDICATED TO INFLATE WITH 10ML IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823303 ↗
• MalfunctionApr 27, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE LAST TIME THIS OCCURRED THE FOLEY BALLOON WAS OVER INFLATED, AS TOO LARGE A SYRINGE WAS USED CAUSING EXTRA PRESSURE, THIS HAPPENED THREE TIMES ON THE SAME PATIENT. IT WAS A DUAL LUMEN FOLEY FOR IRRIGATION AND IT WAS A YELLOW RUBBER MATERIAL, NOT SILICONE LIKE MOST OF THEIR FOLEY CATHETERS. A 10ML SYRINGE WAS USED BUT ONLY 6 ML STERILE WATER WAS DRAWN UP IN THE SYRINGE. THE FIRST CATHETER HELD WATER ON TEST BUT RUPTURED ON USE BUT HAD ONLY BEEN INFLATED WITH APPROXIMATELY 3ML OF WATER WHEN IT RUPTURED. THE SECOND FOLEY BALLOON RUPTURED WHEN TESTED AND SOME PRESSURE WAS APPLIED BEFORE USING ON THE PATIENT. THE THIRD FOLEY BALLOON WAS INSPECTED VISUALLY AND DUE TO LOOKING CRACKED OR DRY-ROTTED WAS NOT EVEN TESTED BASED ON THE OTHER FAILURES . THE PACKAGING FOR THE PRODUCT INDICATED TO INFLATE WITH 10ML IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823296 ↗
• MalfunctionApr 27, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE LAST TIME THIS OCCURRED THE FOLEY BALLOON WAS OVER INFLATED, AS TOO LARGE A SYRINGE WAS USED CAUSING EXTRA PRESSURE, THIS HAPPENED THREE TIMES ON THE SAME PATIENT. IT WAS A DUAL LUMEN FOLEY FOR IRRIGATION AND IT WAS A YELLOW RUBBER MATERIAL, NOT SILICONE LIKE MOST OF THEIR FOLEY CATHETERS. A 10ML SYRINGE WAS USED BUT ONLY 6 ML STERILE WATER WAS DRAWN UP IN THE SYRINGE . THE FIRST CATHETER HELD WATER ON TEST BUT RUPTURED ON USE BUT HAD ONLY BEEN INFLATED WITH APPROXIMATELY 3ML OF WATER WHEN IT RUPTURED . THE SECOND FOLEY BALLOON RUPTURED WHEN TESTED AND SOME PRESSURE WAS APPLIED BEFORE USING ON THE PATIENT. THE THIRD FOLEY BALLOON WAS INSPECTED VISUALLY AND DUE TO LOOKING CRACKED OR DRY-ROTTED WAS NOT EVEN TESTED BASED ON THE OTHER FAILURES . THE PACKAGING FOR THE PRODUCT INDICATED TO INFLATE WITH 10ML IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823295 ↗
• MalfunctionApr 27, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE LAST TIME THIS OCCURRED THE FOLEY BALLOON WAS OVER INFLATED, AS TOO LARGE A SYRINGE WAS USED CAUSING EXTRA PRESSURE, THIS HAPPENED THREE TIMES ON THE SAME PATIENT. IT WAS A DUAL LUMEN FOLEY FOR IRRIGATION AND IT WAS A YELLOW RUBBER MATERIAL, NOT SILICONE LIKE MOST OF THEIR FOLEY CATHETERS. A 10ML SYRINGE WAS USED BUT ONLY 6 ML STERILE WATER WAS DRAWN UP IN THE SYRINGE . THE FIRST CATHETER HELD WATER ON TEST BUT RUPTURED ON USE BUT HAD ONLY BEEN INFLATED WITH APPROXIMATELY 3ML OF WATER WHEN IT RUPTURED. THE SECOND FOLEY BALLOON RUPTURED WHEN TESTED AND SOME PRESSURE WAS APPLIED BEFORE USING ON THE PATIENT. THE THIRD FOLEY BALLOON WAS INSPECTED VISUALLY AND DUE TO LOOKING CRACKED OR DRY-ROTTED WAS NOT EVEN TESTED BASED ON THE OTHER FAILURES. THE PACKAGING FOR THE PRODUCT INDICATED TO INFLATE WITH 10ML IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823289 ↗
• MalfunctionFeb 22, 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 OF UNCLEAR INFORMATION, MISSING INFORMATION, LACK OF MAINTENANCE DOCUMENTATION OR GUIDELINES, INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROFESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418258 ↗
• MalfunctionFeb 22, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THEY WERE ABLE TO SUCCESSFULLY PLACE THE FOLEY CATHER IN A PATIENT BECAUSE IT WAS TO BIG IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418179 ↗
• MalfunctionFeb 22, 2023Illegible Information; Illegible Information

  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 OF UNCLEAR INFORMATION , MISSING INFORMATION , LACK OF MAINTENANCE DOCUMENTATION OR GUIDELINES, INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROFESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418175 ↗
• MalfunctionFeb 22, 2023Missing Information; Missing Information

  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 OF UNCLEAR INFORMATION, MISSING INFORMATION, LACK OF MAINTENANCE DOCUMENTATION OR GUIDELINES, INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROFESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417227 ↗
• MalfunctionFeb 8, 2023Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO AND THEY DID NOT AGREE THAT THEY WERE ABLE TO SUCCESSFULLY PLACE THE FOLEY CATHETER IN A PATIENT BECAUSE NEEDED TO CHANGE THE FOLEY SIZE IN RELATION TO LUBRICATH, 3-WAY, 5CC BALLOON, FRENCH SIZE 20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318495 ↗
• MalfunctionJun 24, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT AND THE BALLOON WAS FOUND TO BE DEFLATED WHILE ATTEMPTING TO PLACE THE CATHETER TO THE PATIENT AFTER SURGERY. PER ADDITIONAL INFORMATION RECEIVED ON 20JUN2022, THE FAILURE OCCURRED IN THE SAME PATIENT WITH THE SAME LOT# (LOT#MYFW0894) AND THE USER STATED THAT ANOTHER CATHETER WAS TAKEN OUT OF THE SAME BOX (LOT#MYFW0894).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800503 ↗
• MalfunctionMay 11, 2018Device Expiration Issue; Crack; Device Expiration Issue

  IT WAS REPORTED THAT THE CATHETER HAD TO BE REMOVED FROM THE PATIENT BECAUSE IT IS CRACKED (SIMILAR TO A ROT). THE CRACK WAS REPORTEDLY NOTICED ALONG THE LENGTH OF THE CATHETER. THE CATHETER WAS REPORTEDLY PLACED ON (B)(6) 2018 AND THE CRACK WAS NOTICED ON (B)(6) 2018; THE CATHETER WAS THEN REPLACED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7509220 ↗