Bardex® Lubricath® Foley Catheter Coude Tip 0168L14Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741017810), received between May 3, 2017 and Sep 28, 2026 — classified as 7 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (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 55 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Difficult to Remove

  Patient problems: Insufficient Information

  MAUDE report 50917216 ↗
• MalfunctionApr 1, 2026Difficult to Remove

  IT WAS REPORTED THAT AFTER USE THE FOLEY CATHETER WATER WOULDN'T DRAIN DUE TO THE CHIMAN STYLE DESIGN, SO THE SHAFT WAS CUT AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758371 ↗
• MalfunctionMar 6, 2026Inflation Problem

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER CAUSED DIFFICULTY IN INJECTING WATER. THE VALVE FOR INJECTING FIXED WATER WAS CRACKED, MAKING IT DIFFICULT TO INJECT WATER, SO IT WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535979 ↗
• MalfunctionJan 26, 2026Material Rupture

  IT WAS REPORTED THAT THERE WAS A RUPTURE IN THE FOLEY CATHETER DURING PLACEMENT AND IT WAS SPONTANEOUSLY EXPELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185610 ↗
• MalfunctionDec 31, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE WATER LEAKED FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936850 ↗
• MalfunctionDec 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT NATURAL REMOVAL OCCURRED OF THE FOLEY CATHETER SEVERAL HOURS AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771989 ↗
• MalfunctionJul 30, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE USE, STERILIZATION PACKAGE OF FOLEY CATHETER WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668540 ↗
• MalfunctionJul 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, FOLEY CATHETER BALLOON WAS FOUND TO BE BROKEN DURING PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509881 ↗
• MalfunctionMay 16, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON DID NOT DEFLATE WHEN THE PATIENT CAME IN A COUPLE OF DAYS LATER TO GET IT REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036252 ↗
• MalfunctionMay 9, 2025Flaked; Flaked

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE SHEDDING PARTICLES (PCN#0168L14 AND PCN#175814).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994701 ↗
• MalfunctionApr 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY BALLOON HAD BURST. IT WAS UNCLEAR IF LOT NUMBER WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917879 ↗
• MalfunctionApr 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THEY HAD ENCOUNTERED WITH THE TWO CATHETERS PURCHASED LUBRI-SIL¿ BARD 175814 LUBRICATH¿ BARDEX 0168L14. AFTER FLUSHING SOLUTION FROM THOSE FOLEY CATHETERS AND THEY OBSERVED LOTS OF PARTICULATE MATTER IN THE FLUSHED LIQUID. AS PER THE MAIL NOTIFICATION RECEIVED ON 07APR2025, THE FOLEYS WERE USED TRANSIENTLY, SOLUTIONS WERE FLUSHED VIA CATHETERS WITHIN 10MIN. THE DETAILS OF THE CATHETERS, LUBRI-SIL CAT# 175814, LOT# NGJT1507; BARDEX , CAT# 0168L14; LOT# NGJP2155. THE FOLEYS WERE USED TO TEST IN CLINICAL USE SIMULATION. IT WAS EXPECTED TO BE IN THE BODY FOR 30MIN. SIMPLY SALINE FLUSHING THROUGH CATHETERS CAUSING PARTICULATE MATTERS, REGARDLESS OF PATIENTS¿ CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848901 ↗
• InjuryApr 14, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PLACEMENT THE FOLEY CATHETER FRACTURED AND THE TIP, END POINT WAS LEFT IN THE BODY DUE TO PATIENT'S SELF-EXTRACTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21832604 ↗
• MalfunctionApr 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE STERILE WATER LEAK FROM THE FOLEY CATHETER BALLOON AND WHEN CHECKED TO SEE THAT THE BALLOON WAS DEFLATED, IT WAS FOUND TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773103 ↗
• InjuryMar 13, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN 84-YEAR-OLD MALE ADMITTED TO HOSPITAL WITH ALTERED MENTAL STATUS. PATIENT HAD A HISTORY OF HYPERLIPIDAEMIA, CORONARY ARTERY DISEASE WITH STENTS, BENIGN PROSTATE HYPERTROPHY, AND DEMENTIA. PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION ALONG WITH INFLUENZA, DURING A PERIOD OF CONFUSION THE PATIENT PULLED THE URINARY CATHETER OUT. THE TIP OF THE CATHETER CONTAINING THE BALLOON SPLIT OFF. A COMPUTED TOMOGRAPHY (CT) OF THE PELVIS INDICATED THE BALLOON WAS RETAINED WITHIN THE PATIENT'S BLADDER. THE NEXT DAY, THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE A CYSTOSCOPY WAS PERFORMED. THE TIP OF THE CATHETER WAS RETRIEVED WITHOUT ANY ISSUES. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY. ALL REMAINING STOCK OF THE CATHETER LOT WAS REMOVED FROM THE ORGANIZATION. THE ALLEGEDLY DEFECTIVE CATHETER WOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21593425 ↗
• MalfunctionDec 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS WAS AN INCIDENT WHERE THE FOLEY CATHETER CRACKED. IT WAS POSSIBLE THAT THE PATIENT MAY HAD TORN IT OFF, BUT IT WAS NOT BROKEN AND WAS NOT LEFT INSIDE THE BODY. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18DEC2024, THAT THE CRACK WAS ON THE INFLATION FUNNEL SIDE OF THE BIFURCATED PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047638 ↗
• MalfunctionDec 31, 2024Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT FOLEY CATHETER CRACK INCIDENT. DUE TO LACK OF ACTUAL ITEMS, A TOTAL OF THREE CASES OCCURRED IN THE SAME WARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047386 ↗
• MalfunctionDec 31, 2024Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT FOLEY CATHETER CRACKED EVENT. THERE WAS A POSSIBILITY THAT THE CATHETER WAS TORN OFF BY THE PATIENT, BUT THE INFORMATION WAS NOT AVAILABLE DUE TO THE DESTRUCTION OF THE ACTUAL CATHETER. A TOTAL OF THREE INCIDENTS OCCURRED IN THE SAME WARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047196 ↗
• MalfunctionJan 9, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2023, AFTER THE FOLEY CATHETER IMPLANTATION, THE STERILE WATER WAS INJECTED AND WHEN THE CATHETER WAS CHECKED TO SEE IF IT COULD BE REMOVED, IT SLIPPED OUT. THE BALLOON WAS DEFLATED. STERILE WATER LEAKED FROM INSIDE THE LUMEN, NOT FROM OUTSIDE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474564 ↗
• MalfunctionDec 4, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT AFTER INSERTING THE FOLEY CATHETER INTO THE PATIENT, THEY COULD NOT CONFIRM THE OUTFLOW OF URINE. SO THEY REMOVED IT AND REINSERTED A NEW CATHETER, WHICH CONFIRMED THE OUTFLOW OF URINE. THERE WAS A POSSIBILITY THAT THERE WAS NO HOLE AT THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256851 ↗
• MalfunctionAug 3, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BURST ONCE INSIDE PATIENT. PROPER AMOUNT OF WATER WAS INSTILLED, SO THE USER WAS UNSURE WHY THE BALLOON BURST. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2023,IT WAS STATED THAT PATIENT STATUS WAS FINE. THE FOLEY CATHETER WAS INSERTED AND A FEW HOURS LATER THE PATIENT CALLED NURSING TO REPORT SINCE THEY FELT A POP AND THAT THEIR CATHETER WAS FALLING OUT. NURSE ASSESSED AND NOTED A SPLIT IN THE BALLOON PART OF THE CATHETER. 10CC WAS INSERTED INTO THE BALLOON AS PER INSTRUCTIONS ON THE CATHETER END. IT WAS STATED THAT THAT THERE WAS SOME SLIGHT TRAUMA TO THE URETHRA, BUT ALSO HAD TO HAVE ANOTHER CATHETER INSERTION SO NOT SURE WHICH CAME FIRST. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 27JUL2023, THE CUSTOMER WAS UNSURE IF THE URETHRA TRAUMA WAS THERE BEFORE THE FIRST CATHETER WAS INSERTED. THERE WAS NO ISSUE WITH THE SECOND CATHETER, IT WAS STATED TO ALERT THAT ANOTHER CATHETER WAS ABLE TO BE PLACED IN THE CUSTOMER DUE TO THE ORIGINAL CATHETER BURSTING. IT WAS REPORTED THAT THE PATIENT STATUS WAS FINE, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 17450303 ↗
• InjuryMar 21, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER GOT BROKEN. ABOUT 25CM OF THE DISTAL PART OF THE CATHETER WAS RETRIEVED, BUT THE CATHETER TIP HAD REMAINED IN THE PATIENT BLADDER WHICH WAS RECOVERED LATER. PER ADDITIONAL INFORMATION RECEIVED VIA INVESTIGATORS NOTIFICATION ON 07MAR2023, STATED THAT THE CATHETER FRAGMENT LEFT BEHIND IN THE PATIENT'S BLADDER WAS SPONTANEOUSLY DISCHARGED FROM THE PATIENT BODY ON MARCH 2. THE SALES REPRESENTATIVE RECOVERED IT ON MARCH 7.THE PATIENT WAS MALE. THE PATIENT WAS HOSPITALIZED IN A PSYCHIATRIC WARD AND HE MAY HAVE SELF-EXTRACTED THE CATHETER. PER FOLLOW UP INFORMATION RECEIVED FROM IBC ON 08MAR2023, CATHETER BREAKAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16583156 ↗
• MalfunctionAug 17, 2022Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD MOLD OR YELLOWING ON THEM. 2 PACKS OF 18 TOTAL OF THE 28 WERE MOLDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15243261 ↗
• MalfunctionJun 10, 2022Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS REMOVED FROM THE PATIENT AND WAS STRAIGHT CATHETERIZED THE PREVIOUS DAY AND FOUND THAT THE CATHETER WAS MISSING ABOUT 3/4 INCH OF ITS TIP. STATED THAT UROLOGY DID NOT FIND IT IN THE PATIENT'S BLADDER AND FELT LIKE THAT MAY HAVE BEEN PRESENT FROM THE BEGINNING DUE TO A MANUFACTURING DEFAULT. ALSO STATED THAT THEY CHECKED THE SUPPLIES IN PACU AND PSU 3 AND THEY ALL APPEARED TO BE FULLY INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655250 ↗
• MalfunctionAug 25, 2021Failure to Infuse; Failure to Infuse

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366206 ↗