Bardex® Lubricath® Foley Catheter Coude Tip 0168L18Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741017834), received between May 12, 2017 and Oct 9, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (4 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THEY MIGHT HAVE ALREADY BEEN NOTIFIED OF THIS, BUT THEY DISCOVERED A CATHETER THAT SAYS ¿COUDE TIP¿ ON THE DESCRIPTION NUMBER ON THE PACKAGING BUT WAS NOT A COUDE TIP ON THE CATHETER, ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257426 ↗
• MalfunctionAug 22, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THEY HAD A DEFECTIVE FOLEY CATHETER. THE REGISTERED NURSE HAD INSERTED THE CATHETER, WENT TO INFLATE THE BALLOON, AND THE FLUID SQUIRTED OUT THE CATHETER IN THE AREA BETWEEN END OF THE CATHETER (INSERTED IN PATIENT) AND THE Y-PORT. THEY TOOK PICTURE OF THE PACKING, AND THEY DO NOT HAVE THE ACTUAL CATHETER. UNFORTUNATELY, THE CATHETER HAD TO BE REMOVED AND REINSERTED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874307 ↗
• MalfunctionJul 25, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT BEFORE USE, FOLEY CATHETER INFLATION VALVE WAS LOOSE OUT OF PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608653 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOLEY CATHETER WAS LEAKING. SUPPLIER: BARD HOME HEALTH DIV 1102424914 07/16/2025 FL 1047. ITEM# 0168L18. BATCH# NGKN2872.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560606 ↗
• MalfunctionMay 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY THE CUSTOMER STATED THAT THE BALLOON ON THE CATHETER WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114809 ↗
• MalfunctionMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088202 ↗
• MalfunctionDec 4, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT INFLATE IN THE CORRECT AREA, INFLATED NEXT TO THE SYRINGE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844390 ↗
• MalfunctionMay 23, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON PART HAS FALLEN OFF THE FOLEY CATHETER. PER FOLLOW UP VIA EMAIL ON 08MAY2024, IT WAS REPORTED THAT PATIENT STATED THAT THE NURSE OPENED THE PACKAGE AND BEFORE INSERTING IT INTO THE PATIENT THE PORT FELL OFF. THERE WAS NO IMPACT TO THE PATIENT AS THE CATHETER BROKE BEFORE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380626 ↗
• MalfunctionJan 23, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS AN ISSUE IMMEDIATELY SO THEY DEFLATED THE BALLOON TO WITHDRAW. THE FOLEY CATHETER WAS STUCK. THEY DEFLATED THE BALLOON AGAIN WHICH WAS EMPTY, SEVERAL ATTEMPTS NO FLUID. REPOSITIONED AND PULLED STRAIGHT UP AND THE BALLOON POPPED AND WAS ABLE TO GET ABOUT 1.5ML MORE OUT OF THE BALLOON AND WAS ABLE TO REMOVE THE FOLEY COMPLETELY. NO PROBLEM WITH THE REPLACEMENT. THE BALLOON SEEMED VERY HARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562423 ↗
• MalfunctionNov 17, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS RUPTURED DURING INFLATION .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159006 ↗
• MalfunctionNov 15, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CUSTOMER HAD A PATIENT THAT ONE OF THE NURSES HAD INSERTED A FOLEY CATHETER, AND WHEN INFLATED THE BUBBLE WAS TORN. THEY HAD TAKEN THE ONES THEY HAD ON THE SHELF OFF. THE PRODUCT WAS BARDEX FOLEY CATHETER 18FR 5CC RIBBED BALLOON CARSON MODEL COUDE TIP LUBRICIOUS COATED. THEY HAD FOUR IN THE OFFICE WITH THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138938 ↗
• MalfunctionOct 26, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013187 ↗
• MalfunctionOct 26, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011493 ↗
• MalfunctionMay 9, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE INDWELLING FOLEY CATHETERS WERE DEFECTIVE, PIN-HOLE IN PORT MAKING INFLATION BALLOON NOT POSSIBLE. ALSO STATED THAT THE CATHETERS WERE UNABLE TO BE USED AND NOT ALL IN THE BOX WERE DEFECTIVE BUT THEY HAD 4-5 IN THE SAME BRAND AND SIZE (18F AND 20F) DO THE SAME THING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894765 ↗
• MalfunctionDec 28, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT AFTER INSERTING THE FOLEY CATHETER AND GETTING URINE RETURN, THE BALLOON ON THE CATHETER WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060320 ↗
• MalfunctionDec 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING ONTO THE BED AND SOAKED THE ENTIRE PAD. IT WAS ALSO REPORTED THAT AFTER CHANGING THE PAD, A SYRINGE WAS ATTACHED TO THE PORT TO DRAW URINE FOR A LAB ORDERED FOR THE PATIENT WHEN THE HUB OF THE PORT BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924098 ↗
• MalfunctionAug 18, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER HAD THE SAME ISSUE WITH THE FOLEY CATHETER TWICE NOW. IT WAS STATED THAT THE FIRST TIME WAS IN APRIL, THE CUSTOMER FELT LIQUID ON LEG ONE NIGHT AND FOUND WATER DRAINING OUT OF ATTACHMENT FOR BALLOON. THE CATHETER COLLAPSED AND SLID OUT . AND THE SECOND TIME WAS TWO WEEKS AGO ON JULY 28TH AT THE DOCTOR'S OFFICE . NURSE REPLACED WITH NEW CATHETER AND THEN IT STARTED DRAINING AGAIN WHILE THEY WERE STILL IN THE DOCTOR'S OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249659 ↗
• MalfunctionDec 20, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED INTO THE URETHRA AND THERE WAS NO URINE FLOW DUE TO NO DRAINAGE EYE ON THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047488 ↗
• MalfunctionJan 29, 2020Partial Blockage; Break; Complete Blockage; Partial Blockage

  IT WAS REPORTED THAT BALLOON DAMAGE WAS FOUND DURING PRETEST. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 13 DECEMBER 2019 FROM IBC REPRESENTATIVE, THERE WERE NO VISIBLE DEFECTS ON THE CATHETER. PER SAMPLE EVALUATION, IT WAS FOUND THAT THE CATHETER'S INFLATION LUMEN WAS OCCLUDED WITH A STICKY MATERIAL.

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

  MAUDE report 9644217 ↗
• MalfunctionJan 27, 2020Fluid/Blood Leak; Material Deformation; Device Fell; Material Deformation

  IT WAS REPORTED THAT THE CATHETER FELL OUT A FEW DAYS AFTER THE PLACEMENT DUE TO A WATER LEAK. PER SAMPLE EVALUATION, IT WAS FOUND THAT THE CATHETER HAD A ASYMMETRICAL BALLOON, AND DEGRADATION WAS ALSO FOUND ON THE CATHETER.

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

  MAUDE report 9632970 ↗
• MalfunctionDec 30, 2019Deflation Problem; Break; Deflation Problem

  IT WAS REPORTED THAT BALLOON DAMAGE WAS FOUND DURING PRETEST. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 13 DECEMBER 2019 FROM IBC REPRESENTATIVE, THERE WERE NO VISIBLE DEFECTS ON THE CATHETER.

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

  MAUDE report 9530501 ↗
• MalfunctionDec 18, 2019Deflation Problem; Deflation Problem; Fluid/Blood Leak; Device Slipped

  IT WAS REPORTED THAT THE CATHETER FELL OUT A FEW DAYS AFTER THE PLACEMENT DUE TO A WATER LEAK.

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

  MAUDE report 9491766 ↗
• MalfunctionMar 11, 2019Leak/Splash

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN CATHETER LEAK. THE PATIENT WAS ADVISED BY HIS PHYSICIAN TO TRY A LARGER CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8410111 ↗
• MalfunctionFeb 5, 2019Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT OF THE PATIENT DURING A PROCEDURE WITH THE BALLOON FULLY DEFLATED. THE COMPLAINANT REPORTED THAT BLOOD WAS FOUND AT THE TIP OF THE MEATUS ALLEGEDLY DUE TO THE CATHETER FALLING OUT. NO MEDICAL INTERVENTION WAS REQUIRED AND NO MISSING PIECE WERE REPORTED.

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

  MAUDE report 8305051 ↗
• MalfunctionJan 7, 2019Deflation Problem

  IT WAS REPORTED TO THAT THE FOLEY WAS UNABLE TO DEFLATE. A NURSE TRIED TO DEFLATE THE FOLEY BY CUTTING BOTH THE BALLOON PORT AND THE CATHETER AND STILL THE BALLOON DID NOT DEFLATE. AT THAT POINT AN UROLOGIST WAS CONTACTED AND WAS ABLE TO REMOVE THE FOLEY BY INSERTING A WIRE TO DEFLATE THE BALLOON AND SLIPPING THE FOLEY OUT.

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

  MAUDE report 8222922 ↗