Bardex® Lubricath® Foley Catheter 0165L22Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741017513), received between Nov 15, 2018 and Nov 25, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT BEFORE USE THE SYRINGE RED SEAL LABEL WAS PEELING OFF AND MAY HAD TRANSFERRED COLOR TO THE GEL. PRINTING DEFECTS ON THE SYRINGE. IT WAS ALSO MENTIONED THAT AS SOON AS THE REPORT WAS COMPLETED, IT WAS NECESSARY TO REPORT THE INCIDENT OF THE ACTUAL DISPOSAL AND THE DIFFICULTY IN DRAINING WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647176 ↗
• MalfunctionJun 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS AN EVENT OF FOLEY CATHETER BALLOON BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329796 ↗
• InjuryApr 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOR SOME TIME NOW, THEY HAD BEEN EXPERIENCING PROBLEMS WITH URINARY CATHETERS CLOSED AND NON-CLOSED SYSTEMS, DOUBLE STREAM OR SINGLE STREAM. THIS ALSO SEEMS TO BE THE CASE IN HOME CARE, BUT NOT IN NEPHROLOGY. URINARY CATHETERS IN PATIENTS WHO HAD VERY LITTLE, OR NO HYDRATION WERE CLOGGED ALL THE TIME, WITH A LOT OF DEPOSITS AND SIGNIFICANT LEAKAGE FROM THE CATHETER. THEY REGULARLY CHANGE THE URINARY CATHETERS FOR LESS THAN 45 DAYS AFTER THEY WERE FITTED, OR EVEN SHORTLY AFTERWARDS AND INCREASE THE LOADING, WITHOUT SATISFACTORY RESULTS. TODAY, THEY CHANGED A CH 20 CLOSED SYSTEM URINARY CATHETER IN A PATIENT WHO WAS RECEIVING LITTLE HYDRATION AND LOW SUBCUTANEOUS HYDRATION, WITH SIGNIFICANT LEAKAGE FROM THE URINARY CATHETER WITH WET PROTECTION. AFTER CHECKING THAT THE FOLEY CATHETER BALLOON WAS INFLATED AND RINSING 60ML FROM THE URINARY CATHETER, AGAIN SIGNIFICANT LEAKAGE IN THE AFTERNOON. THE URINARY CATHETER WAS CHANGED AND THE HOPPER INCREASED TO CH 22. THEY RECOVERED 700 ML, WHEREAS THE PREVIOUS CATHETER WAS INSERTED ON (B)(6) 2024.

  Patient problems: Urinary Retention

  MAUDE report 21797801 ↗
• MalfunctionApr 7, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT FOR SOME TIME NOW, THEY HAD BEEN EXPERIENCING PROBLEMS WITH URINARY CATHETERS CLOSED AND NON-CLOSED SYSTEMS, DOUBLE STREAM OR SINGLE STREAM. THIS ALSO SEEMS TO BE THE CASE IN HOME CARE, BUT NOT IN NEPHROLOGY. URINARY CATHETERS IN PATIENTS WHO HAD VERY LITTLE, OR NO HYDRATION WERE CLOGGED ALL THE TIME, WITH A LOT OF DEPOSITS AND SIGNIFICANT LEAKAGE FROM THE CATHETER. THEY REGULARLY CHANGE THE URINARY CATHETERS FOR LESS THAN 45 DAYS AFTER THEY WERE FITTED, OR EVEN SHORTLY AFTERWARDS AND INCREASE THE LOADING, WITHOUT SATISFACTORY RESULTS. TODAY, THEY CHANGED A CH 20 CLOSED SYSTEM URINARY CATHETER IN A PATIENT WHO WAS RECEIVING LITTLE HYDRATION AND LOW SUBCUTANEOUS HYDRATION, WITH SIGNIFICANT LEAKAGE FROM THE URINARY CATHETER WITH WET PROTECTION. AFTER CHECKING THAT THE FOLEY CATHETER BALLOON WAS INFLATED AND RINSING 60 ML FROM THE URINARY CATHETER, AGAIN SIGNIFICANT LEAKAGE IN THE AFTERNOON. THE URINARY CATHETER WAS CHANGED AND THE HOPPER INCREASED TO CH 22. THEY RECOVERED 700 ML, WHEREAS THE PREVIOUS CATHETER WAS INSERTED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785120 ↗
• MalfunctionFeb 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CUSTOMER HAD FOLEY CATHETER THAT WAS FAULTY. ISSUES WERE THAT UPON INSTILLING STERILE WATER INTO BALLOON, WATER HAD BEGUN LEAKING OUT OF COLOR TAB AND THEN THERE WAS ISSUE OF IF WATER MADE IT INTO BALLOON, THEN IT WOULD NOT DRAIN OUT OF BALLOON. THIS WAS VERY CONCERNING, AND THEY HAD TAKEN BOX OFF OUR SHELF COMPLETELY. IT WAS NOTED THAT THE GIVEN LOT# WAS NGJX4474.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432953 ↗
• MalfunctionFeb 21, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER HAD FOLEY CATHETER THAT WAS FAULTY. ISSUES WERE THAT UPON INSTILLING STERILE WATER INTO BALLOON, WATER HAD BEGUN LEAKING OUT OF COLOR TAB AND THEN THERE WAS ISSUE OF IF WATER MADE IT INTO BALLOON, THEN IT WOULD NOT DRAIN OUT OF BALLOON. THIS WAS VERY CONCERNING, AND THEY HAD TAKEN BOX OFF OUR SHELF COMPLETELY. IT WAS NOTED THAT THE GIVEN LOT# WAS NGJX4474.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432324 ↗
• MalfunctionApr 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DOCTOR INSERTED A MALFUNCTIONED FOLEY CATHETER AND CAUSED A LEAK, SO THEY HAD TO PUT IN ANOTHER CATHETER. THE REPRESENTATIVE ADVISED WOULD SENT REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117144 ↗
• MalfunctionMar 11, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT WHEN THE FOLEY CATHETER BALLOON EXPAND IT POPPED WHEN TRIED TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874971 ↗
• MalfunctionAug 24, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER HAD CATHETER ISSUE. BALLOON FELT FINE-WOULD NOT RELEASE. THEY COULD NOT USE BALLOON STAYED INFLATED. PER FOLLOW UP VIA PHONE ON 17AUG2023, THE CUSTOMER HAD SUPRAPUBIC SURGERY IN JANUARY 2023, AND THIS WAS THE ONLY REPORTED INCIDENT THEY HAD WITH A CATHETER. THE HOME CARE NURSE TRIED TO DEFLATE THE CATHETER, BUT THE FLUID WOULD NOT DRAIN OUT OF IT. THEY CHANGED IT OUT AND DISPOSED OF IT AS IT WAS OF NO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612332 ↗
• MalfunctionSep 27, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY BALLOON PART WAS NOT FULL. THE INCIDENT HAPPENED WHEN IT WAS ON THE PATIENT. IT WAS STATED THAT POST ANESTHESIA CARE UNIT NURSE CHECKED THE BALLOON, THERE WAS A HOLE IN THE BALLOON AND IT WOULD NOT FILL. AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 21SEP2022, IT WAS STATED THAT THERE WAS A PATIENT INVOLVED AND THE HARM WAS TRAUMA WITH RE-INSERTION OF THE CATHETER. THE PHYSICIAN HAD TO COME BACK AND INSERT ANOTHER CATHETER.

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

  MAUDE report 15493989 ↗
• MalfunctionApr 3, 2020Crack; Fluid/Blood Leak; Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ONCE THE CATHETER WAS INSERTED THE PATIENT NOTED THAT IT STARTED LEAKING. THE CUSTOMER THEN REPORTEDLY OBSERVED A CRACK ON THE CATHETER WHICH CAUSED THE LEAK. THE CATHETER WAS REPLACED AND ANOTHER INSERTION TRAY WAS USED.

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

  MAUDE report 9923399 ↗
• InjuryDec 27, 2019Use of Device Problem; Material Fragmentation; Use of Device Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A LATEX ALLERGY, AND WAS USING THE SILICONE COATED FOLEY CATHETER. THE PATIENT NOTED THAT THE SILICONE COATING CAME OFF DURING USE, AND BELIEVED SHE DEVELOPED AN INFECTION AND HAD A PUNGENT SMELL AS A RESULT. NO MEDICAL INTERVENTION WAS REPORTED, HOWEVER, THE PATIENT NOTED THAT SHE HAD A TOPICAL CREAM THAT SHE HAD BEEN USING.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Unspecified Infection; Urinary Tract Infection

  MAUDE report 9526184 ↗
• MalfunctionDec 26, 2019Inaccurate Flow Rate; Inaccurate Flow Rate; Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED THAT THE CATHETER DID NOT DRAIN PROPERLY, WHICH CAUSED URINE TO LEAK AROUND IT. THE BALLOON FILLED UNEVENLY, AND WHEN DEFLATED AFTER BEING FILLED WITH 10CC, ONLY 3CC CAME OUT. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9520589 ↗
• MalfunctionDec 19, 2019Material Deformation; Fluid/Blood Leak; Infusion or Flow Problem; Material Deformation

  IT WAS REPORTED THAT THE CATHETER DID NOT DRAIN PROPERLY, WHICH CAUSED URINE TO LEAK AROUND IT. THE BALLOON FILLED UNEVENLY, AND WHEN DEFLATING AFTER BEING FILLED WITH 10CC, ONLY 3CC CAME OUT. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9497984 ↗
• MalfunctionDec 18, 2019Difficult to Remove; Fluid/Blood Leak; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER DID NOT DRAIN PROPERLY, WHICH CAUSED URINE TO LEAK AROUND IT. THE BALLOON FILLED UNEVENLY, AND WHEN DEFLATED AFTER BEING FILLED WITH 10CC, ONLY 3CC CAME OUT. NO MEDICAL INTERVENTION WAS REQUIRED

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

  MAUDE report 9490046 ↗
• MalfunctionJun 5, 2019Inflation Problem; Particulates; Difficult to Remove

  IT WAS REPORTED THAT THE LUBRICATH FOLEY CATHETER WAS DIFFICULT TO REMOVE. THE CATHETER WAS ULTIMATELY REMOVED BY BEING PULLED OUT OF THE PATIENT. REPORTEDLY WHEN THE CATHETER WAS REMOVED THE BALLOON WAS STILL PARTIALLY INFLATED AND HARD TO THE TOUCH; SEDIMENT WAS ALSO FOUND IN THE TUBING. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

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

  MAUDE report 8669914 ↗
• MalfunctionNov 15, 2018Misassembled; Misassembled; No Flow

  IT WAS REPORTED THAT THE 5CC LUBRICATH CATHETER DID NOT APPEAR TO HAVE THE DRAIN HOLES PUNCHED. DURING VOIDING THE URINE EXITED FROM THE TOP OF THE CATHETER INSTEAD OF THROUGH THE DRAIN HOLE.

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

  MAUDE report 8073571 ↗