Bardex® Lubricath® Foley Catheter 0165L12Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00801741017469), received between Aug 30, 2018 and Sep 11, 2026 — classified as 6 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739950 ↗
• MalfunctionAug 26, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456187 ↗
• InjuryAug 21, 2026Difficult to Remove

  It was reported that when tried to drain 10cc balloon on foley catheter no fluid could be aspirated or removed. Put gentle traction on foley and some resistance was met. Cut syringe connector off the foley and inserted 10cc syringe to tube of y-site directly. Still no fluid could be withdrawn from balloon. Attempted gentle traction on the catheter again and was able to easily remove foley. The balloon was fully deflated on removal. When foley was out of patient writer attempted to fill the balloon with fluid. There was a small hole in the balloon, and the fluid was leaked out of the balloon.

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

  MAUDE report 50382773 ↗
• MalfunctionAug 21, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50382770 ↗
• MalfunctionJun 5, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER SPONTANEOUSLY DISLODGED APPROXIMATELY TWO DAYS AFTER PLACEMENT DUE TO A RUPTURE IN THE BALLOON CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409278 ↗
• MalfunctionMar 12, 2026Material Rupture

  IT WAS REPORTED THAT AT THE TIME OF INSERTING THE FOLEY CATHETER INTO THE PATIENT AND FILLING THE BALLOON WITH WATER, HEALTH PROFESSIONAL DISCOVERED THAT THE BALLOON HAD RUPTURED UPON CONFIRMING ITS FIXATION WITHIN THE BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580954 ↗
• MalfunctionMar 2, 2026Complete Blockage

  IT WAS REPORTED THAT DURING USE THE CATHETER EXPERIENCED MALFUNCTION THAT URINE GETS CLOGGED, THE PATIENT HAS FLOATING MATTER, AND IT ONLY LASTS FOR ONE WEEK, SO IT MUST BE REPLACED IMMEDIATELY, AND THE LOT NUMBER OF THE PRODUCT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489434 ↗
• MalfunctionFeb 27, 2026Material Rupture

  IT WAS REPORTED THAT DURING USE AFTER INSERTION ((B)(6)) THE CATHETER BALLOON WAS RUPTURE ((B)(6)), IT HAPPENED IN 6TH FLOOR WARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475627 ↗
• MalfunctionFeb 25, 2026Material Rupture

  IT WAS REPORTED BY CUSTOMER THAT THE BALLOON TORE DURING INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444436 ↗
• MalfunctionFeb 12, 2026Nonstandard Device

  IT WAS REPORTED THAT DESIGN FAULT IN THE BAG SEAL, AT THE VALVE. SO CHANGED THE URINARY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324834 ↗
• MalfunctionNov 26, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER WAS SPONTANEOUSLY REMOVED 10 DAYS AFTER PLACEMENT OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656157 ↗
• MalfunctionNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT SAID THAT THESE 12 LEAKS. SAID NEEDS 16FR. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497910 ↗
• MalfunctionOct 30, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETESTING THERE WAS DIFFICULTY IN DRAINING WATER FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426375 ↗
• MalfunctionOct 15, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT INSIDE THE STERILIZATION PACK, THE CONTENTS OF THE LUBRICANT JELLY HAD LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292015 ↗
• MalfunctionOct 15, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PRETESTING A HOLE APPEARED IN THE FOLEY CATHETER TUBE CONTAINING THE FIXATIVE WATER, CAUSED WATER TO LEAK. THERE WAS A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290262 ↗
• MalfunctionOct 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS HARD AND DID NOT INFLATE EVEN WHEN THE SYRINGE WAS PRESSED INTO FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221649 ↗
• MalfunctionSep 26, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING PRETESTING THAT THE FOLEY CATHETER STERILE WATER CANNOT BE DRAWN AND HAD DIFFICULTY IN DRAINING WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23154925 ↗
• MalfunctionSep 12, 2025Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT PROBABLY THE PATIENT TORE OFF THE FOLEY CATHETER, BUT CUSTOMER WANT VERIFICATION OF THE WOUND ON THE SHAFT AREA. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 26SEP2025, STATED THAT IT WAS UNKNOWN, WHICH PART OF THE FOLEY CATHETER HAD BEEN TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037573 ↗
• MalfunctionAug 27, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY WENT TO REMOVE A CAD ON A PATIENT, THEY TOOK THE FOLEY CATHETER CUFF OUT UNTIL THEY COULD NOT GET ANY MORE OUT, ABOUT 9 ML. THEN THEY PULLED OUT THE CAD, BUT THE CUFF WAS STILL INFLATED BY ABOUT 1ML. SO, THEY HAVE PULLED OUT THE CAD WITH FLUID LEFT IN THE CUFF. THEY CHECKED HOW MUCH WAS LEFT IN THE CUFF WHEN IT WAS OUT AND GET ABOUT 1 ML OUT, WHICH THEY GET OUT AFTER THEY EMPTY THE SYRINGE. THEY USED TO TAKE THE CUFF OUT WITH THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905078 ↗
• InjuryAug 25, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE CUSTOMER BELIEVES THE SUPRAPUBIC TRAY THEY HAVE NOW WAS LITTLE BIT DIFFERENT THAN THE ONE THEY USED BEFORE. THE INTRODUCER WAS SHARP METALLIC WHICH CAUSED A THROUGH AND THROUGH INJURY TO ONE OF THE PATIENTS. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2025, PATIENT HAD TO UNDERGO SURGERY TO REPAIR THE BLADDER INJURY AND NO SAMPLE AVAILABLE.

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

  MAUDE report 22883336 ↗
• MalfunctionAug 18, 2025Unclear Information; Unclear Information

  IT WAS REPORTED THAT, AFTER DELIVERY CUSTOMER NOTICED THAT THE WRITING ON PACKAGING WAS DIFFERENT. PACKAGING MENTIONED TO USE 5ML AND 10ML IN BALLOON, SO CUSTOMER WAS UNCLEAR AS TO WHAT BALLOON SIZE WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827829 ↗
• MalfunctionJul 31, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BEFORE USE, THE FOLEY CATHETER BALLOON WAS INFLATED WITH STERILE WATER, BUT THE WATER COULD NOT BE REMOVED EVEN AFTER APPLYING NEGATIVE PRESSURE WITH A SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675982 ↗
• MalfunctionJul 25, 2025Material Puncture/Hole; Failure to Infuse; Material Puncture/Hole; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609253 ↗
• MalfunctionJul 11, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT STERILE WATER OF THE FOLEY CATHETER DID NOT DRAIN DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479698 ↗
• MalfunctionJun 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE PRETEST, STERILE WATER DID NOT ENTER INTO THE FOLEY CATHETER AND LEAKED MIDWAY AND WAS UNCONFIRMED FROM WHICH CATHETER BRANCHING PART OR THE VALVE IT LEAKED AND NEED TO INVESTIGATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194200 ↗