Level 1 FC400-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10695085000495), received between Jan 10, 2025 and Jan 10, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A CATHETER EXCHANGE DUE TO INABILITY TO HAVE URINE RETURN FROM BPH. NURSE COLLEAGUE ATTEMPTED TO IRRIGATE FOLEY CATHETER BUT UNABLE TO WITHDRAW. WITHDREW 6ML FROM BALLOON AND STARTED TO PULL, PATIENT WAS VISIBLY UNCOMFORTABLE AND SQUIRMING IN BED, WHEN FOLEY WAS REMOVED THE BALLOON REMAINED PARTLY INFLATED, ANOTHER 4ML EMPTIED FROM CATHETER BALLOON. TRAUMA TO PENIS, MILD BLEEDING AFTER PROCEDURE. TEMP FOLEY THAT WAS REMOVED HAD BALLOON SIZE OF 5ML, 10 ML IN TOTAL REMOVED. UNABLE TO COMPLETELY DEFLATE BALLOON WHILE IN PATIENT BLADDER DESPITE MULTIPLE ATTEMPTS TO ENSURE ALL FLUID REMOVED. LEVEL OF THE HARM WAS MINIMAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Genital Bleeding; Pain

  MAUDE report 21124661 ↗