Bardex® Lubricath® Foley Catheter 0167L24Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741018985), received between Oct 10, 2018 and Aug 25, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441869 ↗
• MalfunctionJun 5, 2026Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER FELL OUT ON ITS OWN THE DAY AFTER SALES REPRESENTATIVE HAD IT PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410441 ↗
• MalfunctionJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A NATURAL REMOVAL EVENT. IT WAS CONFIRMED THAT THE FOLEY CATHETER HAD NATURALLY COME OUT SOME TIME AFTER IT HAD BEEN PLACED IN PLACE DURING SURGERY. AFTER THAT, WATER WAS INJECTED AND THE CATHETER WAS ABLE TO EXPAND, BUT A FUNCTIONAL TEST WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358255 ↗
• MalfunctionSep 19, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DEFLATED IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255917 ↗
• MalfunctionAug 20, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN REMOVING THE URINARY CATHETER AFTER PLACEMENT, THE BALLOON CANNOT BE LOOSENED AND CANNOT BE REMOVED SMOOTHLY. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2024, STATED THAT THE STERILE WATER DID NOT AUTOMATICALLY DRAIN OUT OF THE 10CC SYRINGE AFTER INSERTING IT INTO THE BALLOON VALVE WHEN PERFORMING URINARY CATHETER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002252 ↗
• MalfunctionJul 3, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT EMMETT FOLEY CATHETERS WERE BEING REMOVED FROM STOCK. THEIR SURGEONS USE THESE VERY OFTEN, ESPECIALLY WHEN THEY ARE DOING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THESE PROCEDURES CAN BE VERY LONG, AND THEY WERE VERY VASCULAR. THESE PATIENTS LEAVE THE OPERATING ROOM WITH A FOLEY IN PLACE, AND THEY ARE GETTING CONTINUOUS FLUIDS THROUGH THEIR FOLEY IN POST ANESTHESIA CARE UNIT AND THEY GO HOME WITH A FOLEY AS WELL. THE EMMETT CATHETERS HAVE MORE EYELETS ON THE TIP OF THE CATHETER WHICH HELP THEIR PATIENTS' BLADDERS DRAIN AND IN HOPES, NOT CLOT OFF THE CATHETER WITH BLOOD. IF THE CATHETER DOES CLOT OFF, THEY COULD END BACK IN THE OPERATING ROOM FOR A CLOT EVACUATION. THEY HOPE THIS HELPED AND THEY WERE ABLE TO KEEP THESE CATHETERS HERE IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665641 ↗
• MalfunctionFeb 15, 2024Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE PATIENT HAD 3-WAY CATHETER PLACED IN THE OPERATING ROOM AND THE PATIENT CAME TO THE POST ANESTHESIA CARE UNIT AND THE FOLEY CATHETER BALLOON HAD RUPTURED AND THE CATHETER IN URETHRA PER MD. CATHETER NEEDED TO BE REPLACED AND THE FOLEY CLOTTED OFF. DOCTOR NEEDED TO DO IRRIGATION AND THE FOLEY CHANGED AND THE TUBING FROM CONTINUOUS BLADDER IRRIGATION NOT FLOWING PROPERLY AND THIS ALSO CHANGED OUT AND PATIENT WAS HAVING A OPEN RETROPUBIC SIMPLE PROSTATECTOMY AND PAIN WAS REPORTED IN THE BLADDER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 18710424 ↗
• MalfunctionFeb 9, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT HAD 3-WAY CATHETER PLACED IN THE OPERATING ROOM AND THE PATIENT CAME TO THE POST ANESTHESIA CARE UNIT AND THE FOLEY CATHETER BALLOON HAD RUPTURED AND THE CATHETER IN URETHRA PER MD. CATHETER NEEDED TO BE REPLACED AND THE FOLEY CLOTTED OFF. DOCTOR NEEDED TO DO IRRIGATION AND THE FOLEY CHANGED AND THE TUBING FROM CONTINUOUS BLADDER IRRIGATION NOT FLOWING PROPERLY AND THIS ALSO CHANGED OUT AND PATIENT WAS HAVING A OPEN RETROPUBIC SIMPLE PROSTATECTOMY AND PAIN WAS REPORTED IN THE BLADDER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 18676685 ↗
• InjuryApr 15, 2020Deflation Problem; Difficult to Remove; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LODGED AND DID NOT MOVE AFTER AN ATTEMPT TO PULL IT OUT. 15ML OF FLUID WAS REMOVED FROM THE BALLOON. A UROLOGY PHYSICIAN'S ASSISTANT (PA) WAS CALLED TO ASSIST WITH THE REMOVAL. THE BALLOON PORT WAS CLIPPED BY THE PA , HOWEVER WAS UNABLE TO REMOVE THE FOLEY. THE FOLEY WAS EVENTUALLY REMOVED BY UROLOGY. IT WAS LATER REPORTED VIA EMAIL ON 30MAR2020 THAT THERE WERE NO ADDITIONAL PROCEDURES PERFORMED. IT IS UNKNOWN IF THE HOSPITAL STAY WAS PROLONGED.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 9964699 ↗
• MalfunctionApr 3, 2019Inability to Irrigate; Infusion or Flow Problem; Inability to Irrigate

  IT WAS REPORTED THAT THE INLET PORT DID NOT ALLOW FLUID IN FOR IRRIGATION. THE COMPLAINANT REPORTED THAT THE MD HAD TO MANUALLY IRRIGATE THE DEVICE.

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

  MAUDE report 8480207 ↗
• MalfunctionOct 10, 2018Break; Break

  IT WAS REPORTED THAT THE SEALED INNER PACKAGE WAS BROKEN.

  Patient problems: No Patient Involvement

  MAUDE report 7953734 ↗