Midas Rex MR8 MR8-AF01-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000063542), received between Jan 2, 2024 and Jun 19, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Naturally Worn

  IT WAS REPORTED THAT DURING SERVICING THE BEARINGS WERE RUNNING ROUGH . AT THE TIME OF REPORT NO PATIENT IMPACT IS BEEN OBSERVED .ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563522 ↗
• MalfunctionJun 10, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS BEARING FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452815 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ATTACHMENT BEARING WAS LOOSE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296106 ↗
• MalfunctionJan 2, 2024Material Twisted/Bent; No Apparent Adverse Event; Noise, Audible; Material Twisted/Bent; No Apparent Adverse Event; Noise, Audible

  ON FOLLOW UP IT WAS REPORTED THAT THE ENGINEER INDICATED FAULTY BEARINGS WHICH HAD FAILED, NOT A BENT CRANIOTOME HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424227 ↗