Bardex® Lubricath® Foley Catheter 0165GL16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741046216), received between Apr 12, 2019 and Oct 7, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT NURSE TESTED THE BALLOON OF FOLEY CATHETER, AND IT WOULD NOT DEFLATE AFTERWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384920 ↗
• MalfunctionMay 1, 2019Break; Incorrect Measurement; Component Missing; Detachment of Device or Device Component; Incorrect Measurement

  IT WAS REPORTED THAT UPON DEFLATION OF THE FOLEY CATHETER, THE TIP OF THE CATHETER WAS NOT PRESENT AND BELIEVED TO HAVE BEEN BROKEN OFF INSIDE OF THE PATIENT. X-RAY AND CYSTOGRAM WERE PERFORMED BUT THE TIP WAS NOT LOCATED. UPON RECEIPT OF SAMPLE, INVESTIGATORS FOUND CATHETER TO BE INCORRECT MEASUREMENT MEASURING AS AN 18FR.

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

  MAUDE report 8567958 ↗
• InjuryApr 12, 2019Deflation Problem

  IT WAS REPORTED THAT THE CATHETER WOULD NOT DEFLATE. THE PATIENT WAS TAKEN TO SURGERY FOR FOREIGN BODY REMOVAL.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8511183 ↗