Midas Rex MR8 MR8-AVA12DK-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000063818), received between May 26, 2025 and Aug 5, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22711484 ↗
• MalfunctionJun 30, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST INITIATED TO PRODUCT EVENT REASON FOR RETURN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359055 ↗
• MalfunctionMay 26, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084796 ↗