Bardia 123614CERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741171772), received between Mar 11, 2025 and Jan 12, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 12, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER SLIPPED OUT WITH BALLOON DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048946 ↗
• InjuryDec 10, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DOCTOR USED THE FOLEY CATHETER ON PATIENT DURING SURGERY, AFTER SURGERY THEY WANT TO REMOVE IT, BUT THEY COULD NOT. USER COMMENTED THAT BALLOON CAN BE INFLATED BUT NOT DEFLATED AT THAT POINT OF TIME. THEY DECIDED TO REMOVE PATIENT TO WARD. IN WARD, NURSES TRIED TO REMOVE IT BUT STILL COULD NOT DEFLATE IT. HAVE TO SEND PATIENT BACK TO OT TO REMOVE IT VIA LASER. SURGICAL INTERVENTION WAS PROVIDED TO PATIENT. ANOTHER LASER SURGERY WAS PERFORMED TO REMOVE THE CATHETER. PER FOLLOW UP INFORMATION RECEIVED ON 17DEC2025, STATED THAT DOCTOR USED ON PATIENT DURING SURGERY, AFTER SURGERY THEY WANT TO REMOVE IT BUT COULDN'T. USER COMMENTED THAT BALLOON CAN BE INFLATED BUT NOT DEFLATED AT THAT POINT OF TIME. THEY DECIDED TO REMOVE PATIENT TO WARD. IN WARD, NURSES TRIED TO REMOVE IT BUT STILL CAN'T DEFLATE IT. HAVE TO SEND PATIENT BACK TO OT TO REMOVE IT VIA LASER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23769538 ↗
• InjuryMar 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS UNABLE TO DEFLATE, AND THE PATIENT WAS EXPOSED TO URINE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21574478 ↗