Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00801741034152), received between May 24, 2017 and Sep 28, 2026 — classified as 5 injuries, 148 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (42 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 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923637 ↗
• MalfunctionSep 24, 2026Material Fragmentation

  It was reported that the customer had a Bard Medical 14Fr Foley tray system catheter (Reference: (b)(4) was placed on the patient for intravesical chemotherapy. When the nurse went to instill the chemotherapy, the needle-free sampling port, where the Equashield connector was to be attached, was noted to be missing or broken, preventing attachment of the Equashield device for chemotherapy administration. The drainage bag and tubing were removed, and a new bag (Medline Add-A-Cath) was attached to the catheter, which had the correct port. The customer stated that the same issue was observed in multiple kits from the same lot number on the same day.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889830 ↗
• MalfunctionSep 2, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563775 ↗
• MalfunctionMay 6, 2026Material Rupture

  IT WAS REPORTED THAT PATIENT FOLEY CATHETER CAME OUT WHEN THEY WERE ON THE TOILET. WAS NOT PULLED BUT FELL OUT. THERE WAS ABOUT A 5MM U-SHAPED TEAR NOTED IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096384 ↗
• MalfunctionMar 18, 2026Material Puncture/Hole

  IT WAS REPORTED THAT BEDSIDE STAFF REPOSITIONED THE PATIENT AFTER A COMPLAINT OF URINARY URGENCY WHILE A FOLEY CATHETER WAS IN PLACE. REPOSITIONING WAS PERFORMED TO ENSURE THE FOLEY CATHETER WAS NOT OCCLUDED, AT WHICH TIME THE CATHETER WAS FOUND DEFLATED AND LYING ON THE BED. FURTHER INSPECTION IDENTIFIED A LEAK AT THE FOLEY CATHETER PORT SITE NEAR THE SALINE PORT. A NEW FOLEY CATHETER WAS PLACED, AND NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630402 ↗
• MalfunctionMar 13, 2026Gel Leak

  IT WAS REPORTED THAT DURING USE WHILE INSERTING A URINARY FOLEY CATHETER INTO THE PATIENT, THE PRE-FILLED STERILE WATER SYRINGE USED FOR INFLATION BURST AND WAS LEAKING WATER OUT OF THE SIDES. THEN REMOVED SYRINGE FROM CATHETER, DREW UP 10ML STERILE WATER TO USE TO INFLATE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596485 ↗
• MalfunctionJan 23, 2026Material Rupture

  IT WAS REPORTED THAT, FOLEYS CATHETER INSERTED PRIOR TO TOTAL HYSTERECTOMY AND IT GOT BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172976 ↗
• MalfunctionJan 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT¿S URINARY FOLEY CATHETER WAS FOUND BROKEN, WITH URINE LEAKING FROM THE TUBING. THE PATIENT WAS UNDER A DEPRIVATION OF LIBERTY SAFEGUARDS (DOLS) AND WAS AGITATED AND RESTLESS IN BED. POSEY MITTENS WERE APPLIED TO THE RIGHT ARM AS THE LEFT ARM WAS PLEGIC. THE PATIENT HAD NOT BEEN OBSERVED ACTIVELY PULLING AT THE CATHETER. ON INSPECTION, THERE WAS A CLEAR SPLIT ALONG THE CATHETER TUBING, THOUGH THE STAT LOCK REMAINED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031311 ↗
• MalfunctionJan 9, 2026Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT¿S URINARY FOLEY CATHETER WAS FOUND BROKEN, WITH URINE LEAKING FROM THE TUBING. THE PATIENT WAS UNDER A DEPRIVATION OF LIBERTY SAFEGUARDS (DOLS) AND WAS AGITATED AND RESTLESS IN BED. POSEY MITTENS WERE APPLIED TO THE RIGHT ARM AS THE LEFT ARM WAS PLEGIC. THE PATIENT HAD NOT BEEN OBSERVED ACTIVELY PULLING AT THE CATHETER. ON INSPECTION, THERE WAS A CLEAR SPLIT ALONG THE CATHETER TUBING, THOUGH THE STAT LOCK REMAINED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031075 ↗
• MalfunctionDec 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON ON X2 FOLEY CATHETERS FROM THIS LOT NUMBER HAD BURST WHILE INSIDE THE PATIENT CAUSING THE CATHETER TO FALL OUT AND BE NO LONGER USEABLE. THE PATIENT HAS NOT BEEN INJURED BUT OTHER CATHETERS FROM THIS LOT MAY BE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931065 ↗
• MalfunctionDec 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON INSERTION OF URINARY CATHETER, NOTICED LEAKAGE OF URINE COMING OUT THE ACTUAL CATHETER TUBE. A TEAR WAS FOUND IN THE TUBE (UNABLE TO SEE BEFORE INSERTION AS COVERED IN THE BLUE PACKAGING UPON INSERTION). IMMEDIATELY REMOVED THE CATHETER AND INSERTED A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915492 ↗
• MalfunctionDec 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON CHECKING PATIENT, BED FOUND SOAKING WET AND THE FOLEY CATHETER FOUND BROKEN INTO 2 PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889136 ↗
• MalfunctionDec 19, 2025Unclear Information; Wrong Label; Unclear Information; Wrong Label

  IT WAS REPORTED THAT THEY DISCOVERED THAT ALL OF OUR SUPPLY OF BARD LUBRI-SIL ALL-SILICONE FOLEY CATHETERS SIZES 8FR TO 20FR IN THE STOLLERY OR LEVEL 1 CORE HAVE LABELLING DISCREPANCIES. THE LOT NUMBER ON OUTSIDE OF PACKAGE DID NOT MATCH WITH LOT NUMBER ON PRODUCT INSIDE PACKAGE. THE BALLOON FILL AMOUNTS DO NOT MATCH ON THE 20FR AND 12FR PRODUCTS/PACKAGING. (THE REFERENCE NUMBERS DO APPEAR TO MATCH WITH PRODUCT AND PACKAGING). FOLEY CATHETER SIZE 8FR . FOLEY CATHETER SIZE 10FR . FOLEY CATHETER SIZE 12FR. FOLEY CATHETER SIZE 14FR . FOLEY CATHETER SIZE 16FR . FOLEY CATHETER SIZE 18FR . FOLEY CATHETER SIZE 20FR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850893 ↗
• MalfunctionDec 12, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT FOLEY CATHETER HAD A DIFFERENT LOT NUMBER THAN THE PACKAGING IT CAME OUT OF. THAT WAS THE FIRST TIME THEY HAD HEARD OF THAT COMPLAINT AND WOULD DO EVERYTHING THEY CAN TO GET TO THE BOTTOM OF THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794672 ↗
• MalfunctionDec 5, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A HAIR INSIDE THE UN-OPENED STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735178 ↗
• MalfunctionNov 17, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE REGISTERED NURSE TRIED TO DEFLATE THE BALLOON OF THE FOLEY CATHETER BUT THE FOLEY BALLOON DID NOT DEFLATE ¿ NO SALINE ASPIRATED. NEXT, THIS RN ASPIRATED TWICE, AND AIR FILLED THE SYRINGE. LASTLY, THIS RN TRIED TO DEFLATE THE BALLOON AGAIN AND FINALLY THE BALLOON DEFLATED WITH SALINE ASPIRATED. THE FOLEY CATHETER WAS THEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570316 ↗
• MalfunctionNov 13, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED AND WHEN BALLOON WAS INFLATED THERE WAS A PINHOLE LEAK NEAR INSERTION PORT. FOLEY WAS REMOVED AND NEW FOLEY INSERTED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542965 ↗
• MalfunctionNov 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER KEPT DEFLATING DUE TO SMALL HOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533670 ↗
• MalfunctionNov 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE OPERATING STAFF WAS STATED THERE WAS A HOLE IN THE CATHETER ALONG THE SEAM. THE FOLEY CATHETER BALLOON DID NOT STAY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512474 ↗
• MalfunctionNov 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED FOR SCHEDULED CESAREAN SECTION. ATTEMPTED TO INFLATE FOLEY BALLOON, FLUID FROM SYRINGE WENT DIRECTLY TO FOLEY BAG, THUS THE BALLOON COULD NOT BE INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497745 ↗
• MalfunctionNov 7, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN INFLATING BALLOON IN FOLEY THE SALINE FLUSH SQUIRTED OUT OF SITE AND DID NOT INFLATE. SECOND CATHETER HAD TO BE PLACED FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494943 ↗
• MalfunctionNov 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER PLACED AND WHEN CATHETER BALLOON WAS INFLATED, THE FLUID SQUIRTED OUT OF THE Y JUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494841 ↗
• MalfunctionNov 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT DURING A POSITION CHANGE. UPON EVALUATION THE BALLON DID NOT APPEAR TO BE INFLATED. WHEN REINFLATED THE BALLON QUICKLY DEFLATED DUE TO A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494840 ↗
• MalfunctionNov 6, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT EMERGENCY CESAREAN SECTION. FOLEY CATHETER PLACED IN OPERATING ROOM AND NOT DRAINING URINE. CATHETER DISCONTINUED. DIFFERENT LOT NUMBER FOLEY CATHETER PLACED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488457 ↗
• MalfunctionNov 6, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE RN PLACED FOLEY, WENT TO INFLATE BALLOON AND FLUID SHOT OUT OF THE Y SITE. IT FELT LIKE THERE WAS A HOLE. PRODUCT IS IN MANAGER'S OFFICE. NEW FOLEY HAD TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488454 ↗