Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI18Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741025235), received between Jul 9, 2018 and May 11, 2026 — classified as 4 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Material Rupture

  IT WAS REPORTED THAT THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED UPON INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136367 ↗
• MalfunctionFeb 27, 2026Material Puncture/Hole

  IT WAS REPORTED THAT STERILE WATER LEAK FROM THE 2-WAY BRANCH SECTION OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475629 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED BY CUSTOMER THAT THE FOLEY CATHETER LEAKED WHEN THE PATIENT TRIED TO USE IT. THEY HAD ALREADY CREDITED OR REPLACED PRODUCT FOR THE CUSTOMER AND ASKED TO HAVE CREDIT APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264504 ↗
• MalfunctionNov 7, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PINHOLE WAS FOUND IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497915 ↗
• MalfunctionNov 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON NOT STAYING INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478292 ↗
• MalfunctionNov 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT HOLES IN THE BALLOON OF THE FOLEY CATHETERS. MULTIPLE INSTANCES, MULTIPLE LOTS. (LOT# NGKR2001).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466895 ↗
• MalfunctionNov 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT HOLES IN THE BALLOON OF THE FOLEY CATHETERS. MULTIPLE INSTANCES, MULTIPLE LOTS. (LOT# NGKR2001).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466893 ↗
• MalfunctionSep 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THIS WAS AN INCIDENT IN WHICH THE CATHETER WAS PACKAGED IN A BENT POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23180531 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, FEW DAYS AFTER PLACEMENT URINE LEAKAGE FROM THE SIDE OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005910 ↗
• MalfunctionSep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS URINE LEAKAGE FROM THE CONNECTION BETWEEN THE RUNNING TUBE AND THE FOLEY CATHETER, AND THE CATHETER HAD DETERIORATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965933 ↗
• MalfunctionAug 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A LEAKAGE FROM THE FOLEY CATHETER. THERE WAS A PINHOLE IN THE CATHETER, CAUSING URINE LEAKAGE WHILE IT IS IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874248 ↗
• MalfunctionAug 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, PATIENT STARTED USING FOLEY CATHETER IN JUNE, BUT TWO OF THE SIX BALLOONS THE USER USED BURST AND HAD TO BE REMOVED NATURALLY. THE PATIENT WAS IN PAIN AND HAD SOME URINARY LEAKAGE, SO WHEN THE BALLOON WAS REPLACED AND REMOVED, THE USER FOUND SOMETHING THAT LOOKED LIKE A URINARY STONE STUCK TO THE BALLOON. IT WAS UNKNOWN IF THE URINARY STONE CAUSED THE BALLOON TO BURST. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22686648 ↗
• MalfunctionJul 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT, PATIENT STARTED USING FOLEY CATHETER IN JUNE, BUT TWO OF THE SIX BALLOONS THE USER USED BURST AND HAD TO BE REMOVED NATURALLY. THE PATIENT WAS IN PAIN AND HAD SOME URINARY LEAKAGE, SO WHEN THE BALLOON WAS REPLACED AND REMOVED, THE USER FOUND SOMETHING THAT LOOKED LIKE A URINARY STONE STUCK TO THE BALLOON. IT WAS UNKNOWN IF THE URINARY STONE CAUSED THE BALLOON TO BURST. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22628894 ↗
• MalfunctionJul 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED ON (B)(6) 2025, PATIENT MRN# (B)(4) WAS BROUGHT TO OR ROOM #1 FOR A CYSTOSCOPY AND INSERT URETERAL CATHETERS BY THE PHYSICIAN AND A LAPAROSCOPIC LOW ANTERIOR RECTUM RESECTION BY ANOTHER PHYSICIAN. DURING THE CYSTOSCOPY PHYSICIAN WAS UNABLE TO INSERT THE URETERAL CATHETERS BUT WAS ABLE TO PLACE AN 18 FRENCH FOLEY REF# A303418A. AT THE START OF THE PART OF THE PROCEDURE THE FOLEY DID NOT STAY IN THE PATIENT AND FELL OUT OF THE PATIENT. ON REQUEST OF THE PHYSICIAN ANOTHER FOLEY WAS BROUGHT INTO THE ROOM AND PLACED IN THE PATIENT. THAT WAS A 16 FRENCH FOLEY REF# A303416A, AS THE PROCEDURE WAS GOING ON THAT FOLEY FELL OUT AS WELL. TWO MORE 16 FRENCH FOLEYS WERE PLACED REF# A303416A WITH THE SAME RESULTS. AND THEN ATTEMPTED TO PLACE A 16 FRENCH 2WAY COUDE REF# 0170SI16 AND A 18 FRENCH 2WAY COUDE REF# 0102L18 WITH THE SAME RESULTS. PHYSICIAN WAS ASKED TO ASSIST AT THIS POINT AND WAS ABLE TO SUCCESSFULLY PLACE A 20 FRENCH 2WAY COUDE REF# 0102L20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398278 ↗
• InjuryMay 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE FOLEY CATHETER WAS PLACED. ON (B)(6) 2025, THE BALLOON FIXATION MADE IT DIFFICULT TO DRAIN THE WATER, MAKING THE REMOVAL DIFFICULT. THIS WAS A REPORT ON THE PROCEDURE CARRIED OUT AT THE NEARBY TOKUSHIMA MUNICIPAL HOSPITAL AFTER THE BALLOON WAS PLACED AT (B)(6) HOSPITAL AND THE WATER COULD NOT BE REMOVED UPON REMOVAL. AS PER ADDITIONAL INFORMATION RECEIVED ON 09MAY2025, THE BALLOON PUFF WAS PARTIALLY RAISED ON THE ULTRASOUND AND COULD NOT BE DEFLATED EVEN AFTER CUFF WASHING. PERCUTANEOUS PUNCTURE WAS ALSO ATTEMPTED BUT WAS DIFFICULT, AND IT WAS FINALLY REMOVED AFTER SEVERAL WASHES. WHEN THE CUFF WAS CUT AND CHECKED, IT APPEARED THAT THE LUMEN OF THE CUFF HAD DETACHED, AND THE FALSE LUMEN SIDE HAD STOPPED CONTRACTING. THE ALTERNATIVE CATHETER PLACEMENT ITSELF WAS PERFORMED WITHOUT ANY PROBLEMS. AN 18FR SILICONE BALLOON WAS PLACED, AND ALTHOUGH THERE WAS MILD HEMATURIA, THE HOSPITAL BELIEVES THAT THIS WAS NOT CLINICALLY SIGNIFICANT. ANTIBIOTICS WILL BE ADMINISTERED FOR A FEW DAYS.

  Patient problems: Hematuria

  MAUDE report 22077923 ↗
• MalfunctionMay 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE AT THE BASE OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061991 ↗
• MalfunctionApr 25, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING POSTOPERATION PERIOD, THE URETHRAL CATHETER CAME OUT AND THE FOLEY BALLOON WAS NOTED TO BE DEFLATED. THE MD NOTED A PINPOINT LEAK IN THE BALLOON. INTRAOPERATIVELY THE FOLEY WAS PLACED IN THE URETHRA WITH 15-20 CC WITH A RETENTION BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909678 ↗
• MalfunctionFeb 20, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING TESTING, WATER LEAKED FROM THE TIP OF THE FOLEY CATHETER BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421159 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT URINARY TRACT INFECTION LAST TIME WHILE USING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 20684232 ↗
• MalfunctionOct 24, 2024Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY BALLOON HAD FALLEN OUT AND UPON CHECKING THE BALLOON, IT WAS FOUND TO BE TORN. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON 08 OCT 2024, CUFFING WAS PRESENT DURING SAMPLE EVALUATION WHICH CONTAINS SAME BATCH INFORMATION AS ORIGINAL COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523621 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT STERILE WATER LEAKED NEAR THE VALVE OF THE FOLEY CATHETER DURING A PRETEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20004614 ↗
• MalfunctionJul 19, 2024Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING INTRAOPERATIVE USE, WHEN THE CATHETER WAS INSERTED INTO THE PATIENT AND STERILE WATER WAS ADDED, THE BALLOON DID NOT INFLATE, AND STERILE WATER LEAKED OUT FROM THE CONNECTOR PART. NO INSTRUMENTS OR OTHER ITEMS WERE USED AT THE TIME OF INSERTION. IT WAS NOTED THAT THE GIVEN LOT# WAS MYJP4389.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781799 ↗
• MalfunctionJul 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY BALLOON HAD FALLEN OUT AND UPON CHECKING THE BALLOON, IT WAS FOUND TO BE TORN. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON 08OCT2024, CUFFING WAS PRESENT DURING SAMPLE EVALUATION WHICH CONTAINS SAME BATCH INFORMATION AS ORIGINAL COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690909 ↗
• MalfunctionJul 8, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT STERILE WATER LEAKED FROM THE BALLOON. THE CATHETER WAS USED ON 16JUN2024 AND THE NEXT DAY, IT WAS CONFIRMED THAT THE BALLOON HAD COME LOOSE AND THERE WAS A HOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689744 ↗
• MalfunctionApr 25, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CUSTOMER HAD TROUBLE REMOVING THE FOLEY CATHETER. THEY WERE NOT SURE IF IT WAS BALLOON CUFFING, AND THE BALLOON WAS NOT FULLY DEFLATED OR WHAT THE EXACT ISSUE WAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180527 ↗