Midas Rex MR8 MR8-AD03-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000063535), received between Mar 9, 2025 and Oct 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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.

• MalfunctionOct 23, 2025Overheating of Device; Naturally Worn; Overheating of Device; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368962 ↗
• MalfunctionMar 9, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556294 ↗