Midas Rex MR8 MR8-AVS10 (UDI 00643169912588)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169912588), received between Sep 16, 2024 and Sep 25, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionSep 25, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. It was reported that there was no patient impact. Additional information was received stating that bearing misaligned were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895591 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component

  It was reported that the equipment fell off during cleaning. There was no patient impact. Additional information received stating some bearings are detached due to external force.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689803 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515265 ↗
• MalfunctionApr 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT WAS DEFECTIVE. THE ALLEGATION IS NOT SPECIFIC IN NATURE. AT THE TIME OF THE REPORT, 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 24796147 ↗
• MalfunctionSep 17, 2024Vibration; No Apparent Adverse Event; Vibration; No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS HANDPIECE DISTENSION AND VIBRATION OF DRILL. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20234933 ↗
• MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226037 ↗