Bardex® Lubricath® Foley Catheter 0167L20Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741018961), received between Dec 15, 2020 and Aug 17, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (9 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286646 ↗
• MalfunctionJul 27, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022154 ↗
• MalfunctionJun 27, 2026Material Puncture/Hole

  IT WAS REPORTED THAT WHEN STERILE WATER WAS INJECTED INTO THE FOLEY CATHETER, WATER LEAKED OUT FROM SOMEWHERE AND THE BALLOON WAS NO LONGER INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25646141 ↗
• MalfunctionMar 17, 2026Material Rupture

  IT WAS REPORTED THAT THE BALLOON SUFFERED A RUPTURE AND WAS NATURALLY EXPELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622024 ↗
• MalfunctionFeb 12, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER STERILE WATER LEAKAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328746 ↗
• MalfunctionJan 6, 2026Material Rupture

  IT WAS REPORTED THAT USED FROM DECEMBER 3RD TO DECEMBER 23RD. THE FOLEY CATHETER BALLOON HAD BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981435 ↗
• MalfunctionDec 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED AFTER THE OPERATION, BUT THE BALLOON RUPTURED TWO DAYS LATER AND WAS REMOVED NATURALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763757 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE THE PATIENT WAS USING THE DEVICE, FLUID LEAKAGE WAS OBSERVED FROM THE FOLEY CATHETER SHAFT SECTION DURING PATIENT USE, PROMPTING DISCONTINUATION OF USE. MULTIPLE SCRATCHES WERE NOTED ON THE SHAFT SECTION, AND IT WAS REPLACED WITH A NEW ONE. THERE WERE ABOUT THREE SCRATCHES ON THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23518902 ↗
• MalfunctionNov 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT EVEN WHEN STERILE WATER WAS INFUSED IN THE FOLEY CATHETER, THE BALLOON DEFLATES AND STERILE WATER LEAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497584 ↗
• MalfunctionNov 5, 2025Scratched Material; Scratched Material

  It was reported that while the patient was using the device, Fluid leakage was observed from the foley catheter shaft section during patient use, prompting discontinuation of use. Multiple scratches were noted on the shaft section, and it was replaced with a new one. There were about three scratches on the shaft.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478643 ↗
• MalfunctionSep 22, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE FOLEY CATHETER CUFF. STERILE WATER LEAKED OUT OF THE CUFF DURING THE PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110203 ↗
• MalfunctionJun 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT 2ND DAY AFTER PLACEMENT OF THE FOLEY CATHETER, IT WAS NATURALLY REMOVED DUE TO STERILE WATER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358562 ↗
• MalfunctionJun 11, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT IMMEDIATELY AFTER THE OPERATION, URINE LEAKAGE OCCURRED FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185683 ↗
• MalfunctionMay 30, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING USE, THE CAP WAS NOT ATTACHED IN THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114067 ↗
• MalfunctionMar 24, 2025Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER CAP WAS NOT ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677001 ↗
• MalfunctionFeb 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE, WHEN THEY INJECTED WATER INTO THE FOLEY CATHETER, THE BALLOON AT THE TIP DID NOT INFLATE, BUT INFLATED BY HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312165 ↗
• MalfunctionDec 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CATHETER WAS USED IN UROLOGIC SURGERY. THE FOLEY CATHETER WAS REMOVED SPONTANEOUSLY A FEW MINUTES AFTER IT WAS PLACED. WHEN THE CATHETER WAS CHECKED, IT HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988693 ↗
• MalfunctionOct 14, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER NOTICED AFTER A FEW HOURS OF INSERTION, FOLEY CATHETER WAS SPONTANEOUSLY REMOVED. IT SEEMED TO BE THE BALLOON PART LEAK. IT WAS NOTED THAT THE GIVEN LOT# WAS MYHW0213.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439057 ↗
• MalfunctionAug 1, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING PLACEMENT, AFTER BLADDER LAVAGE, THE INFUSION ROUTE WAS CONNECTED TO THE CATHETER FOR CONTINUOUS BLADDER LAVAGE, BUT THERE WAS NO DRIPPING, AND IT DID NOT GO IN WHEN PUSHED WITH A SYRINGE AND DETERMINED THAT THE CATHETER WAS CLOGGED AND EXCHANGED IT FOR A NEW PRODUCT. WHEN THEY CHECKED THE TIP, END POINT OF THE FIRST CATHETER, THERE WAS NO HOLE. IT WAS NOTED THAT THE GIVEN LOT# MYHU2551.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19882758 ↗
• MalfunctionSep 15, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON WAS DOING A CYSTOLITHOLAPAXY PROCEDURE WHEN PLACING THE LUBRICATH, 3-WAY, SPECIALTY, LATEX, MEDIUM ROUND TIP, TWO STAGGERED DRAINAGE EYES AROUND THE BLADDER AS THEY WENT TO INFLATE THE BALLOON IT WOULD NOT INFLATE AND THEY NOTICED A HOLE IN IT. THEY HAD THE ACTUAL DEVISE AND COULD SEND IT IN FOR INVESTIGATION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754614 ↗
• InjuryJul 10, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT HAD A THREE-WAY INDWELLING FOLEY CATHETER (20 F) THAT WAS BEING MANUALLY IRRIGATED EVERY 1 TO 2 HOURS. THE ORDERS INDICATED TO IRRIGATE WITH 30-60 ML EVERY 1 TO 2 HOURS. AT 13:00 THE NURSE WAS GOING TO IRRIGATE THE CATHETER WHEN NURSE NOTICED THE CATHETER WAS ALMOST TOTALLY OUT OF THE URETHRA. THE NURSE CONTACTED HOSPITALIST WHO FURTHER REVIEWED THE CATHETER, WHICH WAS NOT TOTALLY INTACT, WITH A MISSING PORTION OF THE CATHETER IN AN AREA OF 3 TO 6 CM FROM THE TIP OF THE CATHETER. THE PORTION OF THE CATHETER MISSING APPEARS TO BE THE BALLOON PORTION OF CATHETER. THERE WAS QUESTION OF WHETHER ANY OF THE MANUAL IRRIGATION WAS UNDERTAKEN IN THE PORT WHERE THE BALLOON WAS FILLED TO 10 ML TO HELP SECURE THE CATHETER PLACEMENT. THE CATHETER WAS REPLACED WITH ANOTHER 20 F, 3-WAY CATHETER. PATIENT REQUIRED CYSTOSCOPY COMPLETED ON (B)(6) - RETAINED FOLEY CATHETER BALLOON WAS VISUALIZED AND GRASPED USING FORCEPS AND REMOVED IN ITS ENTIRETY. PATIENT TOLERATED THE PROCEDURE WELL. SCOPE WAS REMOVED. NO IMMEDIATE COMPLICATIONS IDENTIFIED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17286977 ↗
• MalfunctionAug 9, 2021Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT CATHETER BALLOON PORT WAS BROKEN WHEN TRIED TO INFLATE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294188 ↗
• MalfunctionJul 28, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED AND FELL OFF FROM THE PATIENT. THEN THE CUSTOMER REPLACED WITH NEW A CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240382 ↗
• MalfunctionApr 9, 2021Burst Container or Vessel; Decrease in Pressure; Burst Container or Vessel; Decrease in Pressure

  IT WAS REPORTED THAT BALLOON RUPTURED AND FELL OFF. A NEW FOLEY HAS BEEN UNPACKED TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641996 ↗
• MalfunctionDec 15, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER COULD NOT BE INFLATED. A NEW FOLEY CATHETER HAD BEEN UNPACKED TO USE.

  Patient problems: No Patient Involvement

  MAUDE report 11012705 ↗