Midas Rex MR8 MR8-AVS07-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000063870), received between Mar 25, 2025 and Jun 25, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618453 ↗
• MalfunctionJun 17, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530915 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF REMOVAL DIFFICULTY. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498921 ↗
• MalfunctionJun 13, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING WAS MISALIGNED FOUND IN EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494564 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT BEARINGS WAS FELL OUT. AT THE TIME OF REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25468867 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN INTRAOPERATIVE PROCEDURE, THE BEARING ASSOCIATED WITH THE ATTACHMENT FELL OUT AND WAS MISSING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453082 ↗
• MalfunctionJun 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING PREOP FROM THE ATTACHMENT BEARINGS FELL OFF. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426549 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING INTRA OP DEVICE HAD BEARING FELL OUT AND MISSING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298189 ↗
• MalfunctionApr 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, PRIOR TO USE, THE BEARINGS FELL OUT OF ATTACHMENT. THERE WAS NO PATIENT INVOLVED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25040362 ↗
• MalfunctionMar 25, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685499 ↗