Midas Rex MR8 MR8-AVA09Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169912694), received between Sep 27, 2024 and Jan 9, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109740 ↗
• MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PROBLEM NOT REPORTED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20319167 ↗