DeRoyal 81-080410Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756045797), received between Feb 20, 2025 and Aug 20, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionAug 20, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  A USER FACILITY REPORTED THROUGH A MEDWATCH (# (B)(4)), "THE TEMPERATURE PROBE FUNCTIONING UPON INSERTION [DATE REDACTED]. ON [DATE REDACTED]: THE NEXT DAY, IT BEGAN TO INTERMITTENTLY READ INCORRECTLY, GOING FROM 37.0 TO 11.4 AND BOUNCING AROUND, THEN READING STEADY. TEMPERATURE PROBE COMPLETELY STOPPED WORKING ON [DATE REDACTED]: THE SECOND DAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852914 ↗
• MalfunctionAug 8, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "THE END OF EACH FOLEY KEEPS COMING APART."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749637 ↗
• MalfunctionFeb 20, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "CATHETER BROKE INSIDE A PEDIATRIC PATIENT, AND REQUIRED ANOTHER SURGERY TO BE DONE".

  Patient problems: Foreign Body In Patient

  MAUDE report 21425965 ↗