Bard® Lubricath® Foley Catheter 366716Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741077845), received between Nov 9, 2018 and Feb 19, 2020 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2020Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT IT WAS DIFFICULT TO DEFLATE THE BALLOON OF THE CATHETER. REPORTEDLY, ONLY 5 CC OF FLUID WAS ABLE TO BE WITHDRAWN FROM THE CATHETER. WHEN THE CATHETER WAS REMOVED, THE BALLOON WAS STILL PARTIALLY INFLATED. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS NOT PRETESTED.

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

  MAUDE report 9726433 ↗
• MalfunctionNov 9, 2018Migration or Expulsion of Device; Deflation Problem; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON MIGRATED INTO THE URETHRA WHILE IT WAS STILL INFLATED. THIS EVENT OCCURRED AFTER THE FOLEY CATHETER WAS STEPPED ON. ALLEGEDLY, THERE WAS DIFFICULTY REMOVING THE CATHETER FROM THE PATIENT'S URETHRA AND THE NURSE WAS UNABLE TO DEFLATE THE BALLOON WHILE USING A 30CC SYRINGE. PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC REPRESENTATIVE ON (B)(6) 2018, THE ADULT PATIENT STEPPED ON THE FOLEY CATHETER. THE BALLOON MIGRATED FROM HIS BLADDER INTO HIS URETHRA. THE NURSE REMOVED THE FOLEY CATHETER WHILE THE BALLOON WAS STILL INFLATED AND THE PATIENT HAD BLOOD IN HIS URINE.

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

  MAUDE report 8056849 ↗