Midas Rex MR8 MR8-AVS09 (UDI 00643169912625)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169912625), received between Mar 23, 2026 and Jun 22, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Naturally Worn

  IT WAS REPORTED THAT THE BEARINGS WERE LOOSE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573074 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INTRAOP, THE ATTACHMENT BEARING FELL OUT.  IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453995 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT DURING PRE-OP, THE ATTACHMENT HAS BEARINGS ISSUE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328137 ↗
• MalfunctionMay 15, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE TEMPERATURE WAS INCREASING DURING PRE-OPERATIVE PROCEDURE. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185001 ↗
• MalfunctionMay 12, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF REPORT NO PATIENT OR STAFF IMPACT IS BEEN OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147498 ↗
• MalfunctionMar 23, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. AT THE TIME OF THE REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671362 ↗