Midas Rex MR8 MR8-AVS15 (UDI 00643169912601)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169912601), received between Mar 20, 2025 and Jun 15, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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 15, 2026Vibration

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT DRILL BIT WOBBLES. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499216 ↗
• MalfunctionJun 12, 2026Overheating of Device

  IT WAS REPORTED THAT THERE WAS TEMPERATURE INCREASE DURING FIELD SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491476 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING POST OP ATTACHMENT, DURING CLEANUP, BEARINGS FELL OUT. IT WAS REPORTED THERE WAS NO PATIENT IMPACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330189 ↗
• MalfunctionMar 20, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650159 ↗