DeRoyal 81-080408Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00749756045803), received between Nov 29, 2018 and Jul 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073941 ↗
• MalfunctionAug 12, 2025Failure to Sense; Material Integrity Problem; Failure to Sense; Material Integrity Problem

  A USER FACILITY REPORTED ON A MEDWATCH, "FOLEY TEMPERATURE PROBE WIRE EXPOSED. TEMPERATURE FUNCTION NO LONGER USED. FOLEY STILL IN PATIENT, BELIEVED TO BE 8FR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786248 ↗
• MalfunctionFeb 20, 2025Failure to Sense; Failure to Sense

  A USER FACILITY REPORTED, "THE FOLEY IS TESTED, WORKS, PLACED IN PATIENT AND THEN NO LONGER WORKS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425966 ↗
• MalfunctionAug 9, 2024Burst Container or Vessel; Burst Container or Vessel

  A USER FACILITY REPORTED, "BALLOON BURST IN PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951599 ↗
• MalfunctionAug 9, 2024Burst Container or Vessel; Burst Container or Vessel

  A USER FACILITY REPORTED, "PT IN ICU AND THE BALLOON IN THE CATHETER BURST."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951328 ↗
• MalfunctionAug 9, 2024Burst Container or Vessel; Burst Container or Vessel

  A USER FACILITY REPORTED, "BEING USED IN A PT IN THE ICU AND THE BALLOON BURST."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951305 ↗
• MalfunctionAug 9, 2024Burst Container or Vessel; Burst Container or Vessel

  A USER FACILITY REPORTED, "CHECKED BALLOON AND WATER EVERYWHERE AND UPON REMOVING FROM PATIENT DISCOVERED IT HAD BURST."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951288 ↗
• MalfunctionAug 7, 2024Burst Container or Vessel; Material Puncture/Hole; Device Dislodged or Dislocated; Burst Container or Vessel; Material Puncture/Hole; Device Dislodged or Dislocated

  BURST FOLEY BALLOON, LED TO DISLODGEMENT OF INDWELLING URINARY CATHETER. LARGE HOLE NOTED IN BALLOON ON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927886 ↗
• MalfunctionSep 9, 2019Crack; Material Integrity Problem; Crack; Material Integrity Problem

  WHEN THE BABY'S DIAPER WAS OPENED, THE FOLEY CATHETER WAS FOUND CRACKED WITH THE BALLOON DEFLATED. THE CATHETER HAD FALLEN APART. THE PRODUCT WAS BEING USED TO MEASURE THE PATIENT'S BODY TEMPERATURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8977597 ↗
• MalfunctionNov 29, 2018Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  THE TEMPERATURE PROBE WIRES WERE PROTRUDING FROM THE CATHETER, WHICH PLACED THE PATIENT AT RISK FOR SIGNIFICANT URETHRAL INJURY. THE CATHETER WAS REMOVED AND REPLACED, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Patient Involvement

  MAUDE report 8116868 ↗