Bardex® Lubricath® Foley Catheter Councill Model 0196L22Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741017957), received between Jul 12, 2017 and Feb 3, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Fell” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE LATEX FOLEYS WERE NOT STAYING INFLATED AND WERE FALLING OUT OF PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250907 ↗
• MalfunctionJan 31, 2020Expiration Date Error; Material Split, Cut or Torn; Device Fell; Expiration Date Error

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT WITH A LARGE SLIT FOUND ON THE BALLOON. PER SAMPLE EVALUATION, IT WAS FOUND THAT THE CATHETER DATECODE APPEARED TO HAVE A PRINTING ERROR, THE CATHETER PACKAGING WAS MISSING AN EXPIRATION DATE, AND ACCORDING TO THE NOGALES JDE SEARCH, THE CATHETER WAS EXPIRED.

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

  MAUDE report 9653530 ↗
• MalfunctionJan 31, 2020Inadequate Instructions for Healthcare Professional; Expiration Date Error; Material Split, Cut or Torn; Device Fell; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT WITH A LARGE SLIT FOUND ON THE BALLOON. PER SAMPLE EVALUATION, IT WAS FOUND THAT THE CATHETER DATECODE APPEARED TO HAVE A PRINTING ERROR, THE CATHETER PACKAGING WAS MISSING AN EXPIRATION DATE, AND ACCORDING TO THE NOGALES JDE SEARCH, THE CATHETER WAS EXPIRED.

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

  MAUDE report 9653528 ↗
• MalfunctionNov 5, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT WITH A LARGE SLIT FOUND ON THE BALLOON. ADDITIONAL INFORMATION: 21OCT2019 - CUSTOMER UPDATED: THIS ITEM WAS USED ON A PATIENT. THE PATIENT RETURNED STATING THE CATHETER FELL OUT, AND THE BALLOON WAS NO LONGER DEFLATED. I NOTICED UPON CLOSER INSPECTION A CUT IN THE BALLOON. THERE WAS NO PATIENT INJURY, AND THE PATIENT WAS RE-CATHETERIZED WITH NO ISSUES. THERE WAS NO LIFE THREATENING STATE, NO PERMANENT IMPAIRMENT AND THE ONLY INTERVENTION WAS TO PLACE A NEW CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280101 ↗
• MalfunctionJul 12, 2017Material Fragmentation

  IT WAS REPORTED THAT WHEN THE CATHETER WAS REMOVED, THE BALLOON WAS NOTED TO BE IN FRAGMENTS. IT WAS LATER REPORTED FRAGMENTS WERE LEFT IN THE PATIENT, HOWEVER THE PATIENT'S FAMILY CHOSE NOT TO HAVE THEM REMOVED. THE CATHETER WAS PLACED BY A PHYSICIAN DURING A CYSTOGRAM ON (B)(6) 2017.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6709449 ↗