Bardex® Lubri-Sil® All-Silicone Foley Catheter 175820Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741034183), received between Mar 28, 2019 and Dec 16, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unclear Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 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. LABELING DISCREPANCIES: 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. THE BALLOON FILL AMOUNTS DO NOT MATCH ON THE 20FR AND 12FR PRODUCTS/PACKAGING: FOLEY CATHETER SIZE 20FR. FOLEY CATHETER SIZE 12FR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822596 ↗
• MalfunctionDec 16, 2025Unclear Information; Unclear Information

  IT WAS REPORTED THAT THE 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 DID NOT MATCH ON THE 20FR AND 12FR PRODUCTS/PACKAGING. THE REFERENCE NUMBERS DO APPEAR TO MATCH WITH PRODUCT AND PACKAGING. LABELING DISCREPANCIES: 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. THE BALLOON FILL AMOUNTS DO NOT MATCH ON THE 20FR AND 12FR PRODUCTS/PACKAGING: FOLEY CATHETER SIZE 20FR. FOLEY CATHETER SIZE 12FR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822268 ↗
• MalfunctionJun 26, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A DEFECTIVE FOLEY CATHETER. THE BALLOON WOULD NOT FILL UP. IT IS UNCLEAR IF LOT NUMBER REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340630 ↗
• InjuryMay 22, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOLEY CATHETER MATERIAL WAS DIFFERENT (SOFTER) WHICH INCREASED FALSE PATHS, WAS MORE DIFFICULT TO INSERT, WHICH HURT THE PATIENT. CUSTOMER HAD A SITUATION WHERE THE CATHETER HAD MADE A KNOT IN THE BLADDER, AND THEY HAD TO DO A CYSTOSCOPY TO CUT THE CATHETER WITH A LASER TO REMOVE IT (B)(4). PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 06MAY2025, THE TIP OF THE CATHETER THAT CONTAINS THE BALLOON IS PROMINENT AND FORMS A RING WHEN THE BALLOON IS DEFLATED. IT WAS ANOTHER ISSUE WITH THE DEFLATION OF THE BALLOON. THE BALLOON REMAINS DEFORMED WHEN DEFLATED, CAUSING INJURY TO THE PATIENT WHEN REMOVING THE INDWELLING CATHETER. THIS WAS APPARENTLY TRUE FOR ALL OUR 100% FOLEY (1658XX) AND LUBRI-SIL (1758XX) MODELS. (B)(4).

  Patient problems: Pain

  MAUDE report 22069848 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 5CC BALLOON (CATHETER TIP) STICKS OUT 1/8 OF AN INCH THE DOCTOR TOLD PATIENT THE BARDEX LUBRISIL FOLEY CATHETERS WERE CAUSING LESIONS ON THEIR BLADDER AND THAT COULD CAUSE CANCER. THE REPRESENTATIVE EXPLAINED TO PATIENT THAT THE BARDEX LUBRISIL FOLEY CATHETER WAS PRETTY STANDARD THERE ARE SOME MANUFACTURES THE HAVE THE BALLOON PLACE HIRER UP FOR EXAMPLE ONES THAT HAVE STAGGERED EYELETS. THE PATIENT WANTED TO KNOW BALLOONS ARE NOT PLACED AT THE VERY END OF CATHETER BECAUSE OF WHERE THE EYELETS MUST BE PLACED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Tissue Breakdown

  MAUDE report 15293515 ↗
• MalfunctionOct 14, 2021Decrease in Pressure; Decrease in Pressure

  HOLD LY 11/16IT WAS REPORTED THAT THE BARDEX LUBRISIL FOLEY CATHETER WAS FAILURE IN DESIGN. CUSTOMER REPORTED THAT THE BALLOON FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631574 ↗
• InjuryMar 28, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED A KIDNEY INFECTION AFTER USING THE FOLEY CATHETER BECAUSE IT WAS NOT AN ALL SILICONE COATED CATHETER. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 8460135 ↗