Bardex® Lubri-Sil® All-Silicone Foley Catheter 175824Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741034206), received between Apr 2, 2019 and May 22, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 (PCN#175812, PCN#175814, PCN#175816, PCN#175818, PCN#175820, PCN#165822 AND PCN#175824). 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. (PCN# 165820, PCN# 165818 AND PCN# 165816).

  Patient problems: Pain

  MAUDE report 22070677 ↗
• InjuryApr 3, 2019Obstruction of Flow; Failure to Advance; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE 24FR SUPRA-PUBIC CATHETER WOULD ONLY GO IN ABOUT 2 INCHES AND THEN STOP. THE PATIENT REPORTEDLY WENT TO THE DOCTOR WHERE THE MD RAN A ROD INTO THE OPENING IN THE STOMACH TO REMOVE WHAT WAS BLOCKING IT AND PREVENTING THE CATHETER FROM BEING INSERTED. THE PATIENT WAS REPORTEDLY SWITCHED TO A 22FR CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8481056 ↗
• MalfunctionApr 2, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT URINE LEAKED FROM THE FOLEY CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8475654 ↗