Bardex® Lubricath® Foley Catheter Female Length 0169L16Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741018008), received between Aug 3, 2018 and Aug 17, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY BALLOON WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240218 ↗
• MalfunctionMar 17, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT FELT THERE WAS NO LUBRICANT WHILE INSERTING AND FELT CATHETER WAS SWELLING INSIDE THE PATIENT. ALSO CUSTOMER HAD CATHETER FOR FEW DAYS AND FELT NEED TO TAKE OUT AND SUPPOSED THERE WAS A CHANGE IN PRODUCT. PER FOLLOW UP VIA PHONE ON (B)(6) 2021, THE CUSTOMER NOTED THAT THE CATHETER STARTS STICKING TO THE PATIENT INSIDE THE URETHRA AFTER ABOUT OF WEEK OF USE AND GETS WORSE AS TIME PROGRESSES. IT WAS NOTED THAT 2 USED SAMPLES WILL BE SENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510076 ↗
• MalfunctionFeb 22, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT FELT THERE WAS NO LUBRICANT WHILE INSERTING AND FELT CATHETER WAS SWELLING INSIDE THE PATIENT. ALSO THE CUSTOMER WAS HAVING CATHETER FOR FEW DAYS AND FELT THAT THE CATHETER NEED TO BE TAKEN OUT AND SUPPOSED THAT THERE WAS A CHANGE IN PRODUCTS

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11363038 ↗
• MalfunctionAug 3, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY BEGAN EXPERIENCING PAIN AND SLIGHT BLEEDING A FEW DAYS AFTER THE CATHETER WAS PLACED SUPRAPUBICALLY. THE CATHETER WAS SLIDING IN AND OUT SO HE TAPED THE CATHETER TO HIS STOMACH IN ATTEMPT TO KEEP IT IN PLACE. WHEN HE WENT TO HAVE THE CATHETER REMOVED AFTER ABOUT A WEEK OF USE, THE CATHETER SHOT ACROSS THE ROOM AND THE DOCTOR NOTED THAT THERE WAS A HOLE IN THE BALLOON. COMPLAINANT NOTED THE CATHETER FELT SECURE WHEN IT WAS FIRST PLACED. NO PIECES OF THE BALLOON WERE REPORTED TO BE MISSING AND NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PAIN OR BLEEDING.

  Patient problems: Pain

  MAUDE report 7746355 ↗