Bardex® Lubricath® Foley Catheter Coude Tip 0168L16Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00801741017827), received between Apr 19, 2017 and Jun 5, 2026 — classified as 7 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (11 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 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Difficult to Remove

  IT WAS REPORTED BY CUSTOMER THAT THE 5 CC COUDE TIP TWO WAY PRE LUBRICATED CATHETER AFTER INSERTION, RESISTANCE WAS MET INFLATING THE BALLOON, AND ONLY 2ML OF SALINE WAS INSTILLED. UNABLE TO WITHDRAW 2ML OF SALINE TO REMOVE FOLEY. SURGICAL RESIDENT WAS UNABLE TO ALSO REMOVE SALINE FROM BALLOON BUT WAS ABLE TO REMOVE FOLEY. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409245 ↗
• MalfunctionMar 17, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE NURSE HAD INSERTED THE COUDE CATHETER INTO A PATIENT AND LATER ON THAT SHIFT, THE FOLEY BALLOON HAD DEFLATED ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621777 ↗
• MalfunctionOct 15, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN CUSTOMER WENT TO INFLATE THE BALLOON THE TOP OF THE PORT STARTED BUBBLING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278316 ↗
• MalfunctionOct 10, 2025Material Puncture/Hole; Device Dislodged or Dislocated; Material Puncture/Hole; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SINCE PRODUCT WAS ALREADY USED, CUSTOMER CHECKED THE OUTSIDE OF THE BAG, BUT NO CRACKS OR OTHER DAMAGE WERE FOUND IN THE BALLOON OF THE FOLEY CATHETER. IT SEEMS THAT IT CAME OUT NATURALLY AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270464 ↗
• MalfunctionJul 31, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHILE USING PRODUCT NURSING STAFF WERE PLACING A FOLEY CATHETER AND THE VALVE FOR FILLING THE BALLOON WITH STERILE WATER CAME OFF THE LINE, CAUSING THE CONTENTS TO LEAK. THEY WERE UNABLE TO RE-ATTACH THE VALVE. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 13AUG2025, STATED THAT DURING FOLEY PLACEMENT FOR INTRAVESICAL TREATMENT THE VALVE FOR FILLING THE BALLOON WITH STERILE WATER CAME OFF THE LINE, CAUSING THE CONTENTS TO LEAK. WRITER TRIED TO RE-ATTACH VALVE WITHOUT SUCCESS, SUBSEQUENTLY FILLED BALLOON WITH 10 CC NORMAL SALINE AND CLAMPED WITH LOCKING HEMOSTAT. CATHETER PLACEMENT MAINTAINED FOR TREATMENT WITHOUT DISCOMFORT TO PATIENT AND PROVIDED LOT#NGJZ0494.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679620 ↗
• MalfunctionJun 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THEY INSERTED 4TH FOLEY CATHETER WITHOUT DIFFICULTY INFLATED WITH 10ML STERILE WATER, HEPATO-PANCREATO-BILIARY (HPB) PROVIDER FILLED ADDITIONAL 10ML, UROLOGY PROVIDER FILLED ADDITIONAL 10ML, FOR A TOTAL OF 30ML STERILE WATER IN BALLOON. FOLEY FELL OUT AND TIP OF BALLOON WAS SPLAYED LIKE A FLOWER. PRODUCT WAS ACCIDENTLY THROWN AWAY. ACTIONS HAD BEEN TAKEN SO FAR WAS UROLOGY PROVIDER INSERTED A MEDLINE 16FR 10ML FOLEY WITHOUT DIFFICULTY INSTILLING 20ML. PATIENT 5TH AND CURRENT FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283372 ↗
• MalfunctionApr 28, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PATIENT RECENTLY PURCHASED A BOX OF 12, BARDEX FOLEY CATHETERS MODEL 0168L16, LOT NGJU3558. WITH EACH CATHETER IN THAT BOX, THE VALVE WAS SEATED TOO LOW TO MAKE PROPER CONTACT WITH THE TIP OF THE SYRINGE. THE RESULT WAS THAT THE SYRINGE CANNOT DEPRESS THE VALVE SUFFICIENTLY TO FILL THE BALLOON. THEY HAD BEEN USING BARDEX FOLEY CATHETERS FOR EIGHT YEARS, BUT THAT WAS FIRST TIME THEY HAD EVER ENCOUNTERED THAT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918147 ↗
• MalfunctionApr 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED FOR FOLEY CATHETER EXCHANGE. USING NEW BARD 16 FR COUDE CATHETER THAT HAD PACKAGING INTACT, AND WAS NOT EXPIRED, CATHETER WAS PLACED. IT WAS THEN NOTED THAT URINE WAS LEAKING OUT OF A LARGE TEAR/HOLE NEAR THE END OF THE CATHETER. THIS WAS PROMPTLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900340 ↗
• MalfunctionApr 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON POPPED IN PATIENT'S BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891777 ↗
• MalfunctionApr 17, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER REQUESTED A REPLACEMENT FOR THE FOLEY CATHETER BECAUSE THIS BATCH OF CATHETER WAS NOT THE SAME AS BEFORE, CUSTOMER SAID THAT THE VALVE WAS TOO LOW THAT THE SYRINGE WOULD NOT REACH THE TIP TO FILL IT OUT WITH IRRIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854911 ↗
• MalfunctionApr 15, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT CUSTOMER HAD ANOTHER FOLEY CATHETER ISSUE, THIS TIME WITH NOT BEING ABLE TO DEFLATE THE BALLOON ON TWO DIFFERENT CATHETERS. REF (B)(4) LOT NGJY1147. STAFF HAVE EXPERIENCED DIFFICULTY DEFLATING THE CATHETER BALLOON UNLESS THEY APPLY SIGNIFICANT PRESSURE USING THE SYRINGE UNTIL THEY FEEL A POPPING SENSATION AND THEN COULD ASPIRATE THE FLUID FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840254 ↗
• MalfunctionApr 14, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY HAD ANOTHER CATHETER ISSUE, THAT TIME WITH NOT BEEN ABLE TO DEFLATE THE BALLOON ON TWO DIFFERENT CATHETERS. REF (B)(4), LOT NGJY1147. STAFF HAD EXPERIENCED DIFFICULTY DEFLATING THE CATHETER BALLOON UNLESS THEY APPLY SIGNIFICANT PRESSURE USING THE SYRINGE UNTIL THEY FELT A POPPING SENSATION AND THEN CAN ASPIRATE THE FLUID FROM THE BALLOON. IF THE BD ENGINEERS WANT TO REVIEW THE PRODUCT, THEY HAD ONE OF THE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832650 ↗
• MalfunctionApr 8, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT PRIOR TO INSERTION, BALLOON CHECKED, UNABLE TO DEFLATE THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21796901 ↗
• MalfunctionMar 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT'S FOLEY CATHETER WAS NOT FOUND IN PATIENT'S GENITALS. NURSE INFLATED THE BALLOON TO SEE IF THERE WERE LEAKS OR IF THE BALLOON HAD POPPED. THE BALLOON WAS FULLY INFLATED AND THERE WERE NO SIGNS OR SYMPTOMS OF LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572168 ↗
• MalfunctionMar 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT COUDE TIP FOLEY CATHETER WAS INSERTED INTO PATIENT AND PORT FOR BALLOON INFLATION CAME OFF. CATHETER WAS INFLATED WITH SALINE AND A CATHETER PLUG WAS INSERTED INTO THE BALLOON INFLATION TUBE WHILE REMAINING STERILE. PATIENT WAS COMBATIVE WITH INSERTION AND WOULD NOT ALLOW NURSING TO INSERT NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536180 ↗
• MalfunctionJan 9, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE UPON COMPLETING A CATHETER REMOVAL, SALINE WAS REMOVED FROM THE CATHETER TO DEFLATE THE BALLOON. HOWEVER, DURING REMOVAL OF THE CATHETER, MUCH RESISTANCE WAS MET AND COME TO FIND THE BALLOON WAS STILL INFLATED WITH AIR. THERE HAD NEVER BEEN AN ISSUE WITH THIS TYPE OF CATHETER, AND THE BALLOON HAD ALWAYS DEFLATED. ALL PIECES OF THE CATHETER WERE INTACT. THE PRODUCT DID NOT PERFORM AS INTENDED. PER ADDITIONAL INFORMATION RECEIVED ON 13JAN2025, IT WAS REPORTED THAT THE STERILE WATER WAS USED. THIS WAS PART OF THE PREFILLED KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114563 ↗
• MalfunctionDec 27, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE LEURLOCK ON THE BALLOON PORT FELL OFF WHEN SYRINGE ATTACHED. THIS HAPPENED TWICE BEFORE FOLEY CATHETER WAS INSERTED INTO THE PATIENT. PRODUCT WAS NOT USED ON PATIENT. (DOE# (B)(6) 2024 AND DOE# (B)(6) 2024).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026660 ↗
• MalfunctionNov 27, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT URETHRAL COUDE CATHETER WAS INSERTED INTO PATIENT AND WAS ADVANCED AS FAR AS POSSIBLE WITH BALLOON INFLATED WITH 10ML STERILE WATER. AFTER ONE HOUR, THERE WAS NO URINE RETURNED. CRITICAL RESPONSE NURSE WAS CALLED WITH INABILITY TO REMOVE OR INSTILL ANY STERILE WATER INTO THE BALLOON PORT AND WAS UNABLE TO REMOVE THE CATHETER. PHYSICIAN ASSISTANT-CERTIFIED CALLED TO BEDSIDE AND DETERMINED UROLOGY HAD TO BE NOTIFIED. UROLOGY TO BEDSIDE WITH ATTEMPT TO DISSOLVE THE BALLOON BY ATTEMPTING TO INSTILL 10 ML MINERAL OIL, HOWEVER THAT WAS UNSUCCESSFUL. THE BALLOON PORT OF THE CATHETER WAS DETERMINED TO BE OCCLUDED, AND THE CATHETER WAS DEFECTIVE. A STILL WIRE WAS INSERTED INTO THE SIDE PORT AND TENSION WAS APPLIED TO THE CATHETER TO BREAK IT AND WAS ABLE TO BE REMOVED WITH NO FRAGMENTS UNACCOUNTED FOR. UROLOGY THEN INSERTED A NEW COUDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795741 ↗
• MalfunctionNov 26, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT NURSE TESTED BALLOON ON THE FOLEY CATHETER BEFORE INSERTING INTO PATIENT AND THE BALLOON WOULD NOT DEFLATE WHEN ATTEMPTED TO REMOVE STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786690 ↗
• InjuryNov 26, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT URETHRAL COUDE CATHETER WAS INSERTED INTO PATIENT AND WAS ADVANCED AS FAR AS POSSIBLE WITH BALLOON INFLATED WITH 10ML STERILE WATER. AFTER ONE HOUR, THERE WAS NO URINE RETURNED. CRITICAL RESPONSE NURSE WAS CALLED WITH INABILITY TO REMOVE OR INSTILL ANY STERILE WATER INTO THE BALLOON PORT AND WAS UNABLE TO REMOVE THE CATHETER. PHYSICIAN ASSISTANT-CERTIFIED CALLED TO BEDSIDE AND DETERMINED UROLOGY HAD TO BE NOTIFIED. UROLOGY TO BEDSIDE WITH AN ATTEMPT TO DISSOLVE THE BALLOON BY INSTILLING 10 ML MINERAL OIL, HOWEVER THAT WAS UNSUCCESSFUL. THE BALLOON PORT OF THE CATHETER WAS DETERMINED TO BE OCCLUDED, AND THE CATHETER WAS DEFECTIVE, A STILL WIRE WAS INSERTED INTO THE SIDE PORT AND TENSION WAS APPLIED TO THE CATHETER TO BREAK IT AND WAS ABLE TO BE REMOVED WITH NO FRAGMENTS UNACCOUNTED FOR. UROLOGY THEN INSERTED A NEW COUDE CATHETER.

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

  MAUDE report 20784291 ↗
• MalfunctionNov 8, 2024

  NURSING TESTED BALLOON ON CATHETER BEFORE INSERTING INTO PATIENT; BALLOON WOULD NOT DEFLATE WHEN ATTEMPTED TO REMOVE STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646712 ↗
• MalfunctionSep 10, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT EYELET OF FOLEY CATHETER WAS NOT PUNCHED AND CLOSED. PATIENT CANNOT USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179676 ↗
• MalfunctionSep 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD NOT INFLATE AND CUSTOMER TRIED A SECOND ONE AND HAD NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126944 ↗
• MalfunctionAug 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT FOLEY CATHETER WAS PLACED IN PATIENT AND AFTER PLACEMENT, CATHETER WAS FOUND TO BE DEFECTIVE WITH HOLE IN CATHETER DIRECTLY UNDER THE BALLOON PORT CONNECTION AND NEW CATHETER NEEDED TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19892531 ↗
• MalfunctionMay 17, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WAS PATIENT IN UROLOGY CLINIC FOR ROUTINE FOLEY CATHETER EXCHANGE. PREVIOUS FOLEY CATHETER WAS REMOVED WITHOUT DIFFICULTY. NEW CATHETER WAS INSERTED WITHOUT DIFFICULTY BY NURSE, BUT NURSE WAS UNABLE TO INFLATE OR DEFLATE WITH SYRINGE AND NO URINE DRAINED FROM CATHETER. BALLOON PORT WAS CUT TO ENSURE BALLOON WAS DEFLATED AND CATHETER WAS REMOVED. A SECOND CATHETER WAS PLACED WITHOUT ISSUES BY NURSE AND THEY WERE ABLE TO INFLATE BALLOON AND URINE DRAINING FROM CATHETER AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341799 ↗