Bardex® Lubricath® Foley Catheter Coude Tip 0168L12Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741017803), received between Sep 20, 2017 and Mar 13, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER AFTER RETENTION, A NATURAL REMOVAL EVENT HAD OCCURRED, AND THERE WAS A POSSIBILITY THAT STERILIZED WATER WAS LEAKING FROM THE BALLOON PART BUT SPECIFIC PART WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593702 ↗
• MalfunctionSep 17, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BRANCH SWELLED BECAUSE STERILE WATER WAS NOT INTRODUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235736 ↗
• MalfunctionDec 2, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY RIBBED BALLOON CATHETER WAS FOUND WITH AN ADDITIONAL CATHETER TIP IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905213 ↗
• MalfunctionNov 28, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE RIBBED FOLEY CATHETER BALLOON WAS FOUND WITH AN ADDITIONAL CATHETER TIP IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868298 ↗
• MalfunctionNov 27, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE RIBBED FOLEY CATHETER BALLOON WAS FOUND WITH AN ADDITIONAL CATHETER TIP IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867078 ↗
• MalfunctionSep 7, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS A PATIENT EVENT THAT OCCURRED THE PREVIOUS DAY WHERE A FOLEY CATHETER WAS NOT ABLE TO BE REMOVED FROM THE PATIENT USING TECHNIQUES FROM THE INSTRUCTION FOR USE. IT WAS STATED THAT FROM THE ROOM NURSE'S OBSERVATION, IT WAS NOTICED THAT THE BALLOON WAS NOT ABLE TO BE DRAINED EASILY WHICH MIGHT BE THE REASON FOR THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370207 ↗
• MalfunctionJun 1, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT FOLEY CATHETER CAME OFF ABOUT 10 MINUTES AFTER INSERTING INTO THE PATIENT. AFTER THE CATHETER REMOVAL, THE USER PUT WATER AGAIN INTO THE BALLOON AND IT DEFLATED WHEN THE WATER WAS LEFT FOR ABOUT 5 TO 10 MINUTES. THERE WAS NO BALLOON RUPTURE OR TEAR AND THE PATIENT DID NOT HAVE ANY URINE STONE. IT WAS STATED THAT HAND GLOVE WOULD HAVE POSSIBLY CONTACTED TO THE BALLOON. AS PER THE ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 18MAY2022, NO VISIBLE DAMAGE WAS OBSERVED TO THE RETURNED SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14564962 ↗
• MalfunctionFeb 6, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DIFFICULT TO DEFLATE ON THE NEXT DAY OF THE PLACEMENT. THE PATIENT WAS SENT TO ANOTHER HOSPITAL FOR SUCCESSFUL REMOVAL. PER FOLLOW UP VIA IBC ON 26JAN2022, THE METHOD USED TO REMOVE THE CATHETER WAS PROBABLY CUT AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467684 ↗
• MalfunctionJan 13, 2022Failure to Infuse; Component Misassembled; Failure to Infuse; Component Misassembled

  IT WAS REPORTED THAT WHEN THE SYRINGE WAS CONNECTED TO THE INFLATION FUNNEL AND THE SYRINGE WAS PUSHED, THE FOLEY CATHETER BALLOON DID NOT INFLATE DUE TO WATER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252560 ↗
• MalfunctionJun 19, 2020Component Misassembled; Failure to Align; Component Misassembled

  IT WAS REPORTED THAT DURING THE INVESTIGATION OF THE COMPLAINT, THE COUDE INDICATOR BUTTON WAS NOT ALIGNED WITH THE COUDE CURVE OF THE CATHETER.

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

  MAUDE report 10174950 ↗
• MalfunctionApr 23, 2020Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS DIFFICULT TO INFLATE DURING PRETEST.

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

  MAUDE report 9992868 ↗
• MalfunctionApr 3, 2020Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE DURING PRETEST. PER ADDITIONAL INFORMATION FROM THE INVESTIGATOR VIA EMAIL 23MAY2020; UPON EVALUATION OF THE SAMPLE IT WAS FOUND THAT THE INNER LUMEN OF THE INFLATION FUNNEL WAS COLLAPSED

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

  MAUDE report 9923425 ↗
• MalfunctionOct 10, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER WAS HARD.

  Patient problems: No Patient Involvement

  MAUDE report 9174759 ↗
• MalfunctionOct 7, 2019Break; Device Damaged Prior to Use; Component Missing; Break

  IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, IT WAS NOTED THAT THE CATHETER'S TIP WAS MISSING AND WAS NEVER INSERTED INTO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9161906 ↗
• MalfunctionApr 3, 2019Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON BURST DURING A PRETEST.

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

  MAUDE report 8477708 ↗
• MalfunctionNov 21, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON BURST WHILE INFUSING WATER INTO THE CATHETER DURING A PRETEST.

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

  MAUDE report 8095991 ↗
• MalfunctionOct 10, 2018Difficult to Insert; Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DIAMETER OF THE FOLEY CATHETER WAS LARGER THAN USUAL. THE PATIENT ALLEGEDLY WAS UNABLE TO INSERT THE CATHETER. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 7951067 ↗
• MalfunctionSep 20, 2017Inflation Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE BALLOON OF THE CATHETER WITH WATER DURING PRETEST. ANOTHER CATHETER WAS USED FOR THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6880272 ↗