Midas Rex MR8 MR8-AS10-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000063610), received between Apr 12, 2022 and Sep 15, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. No patient complications have been reported as a result of this event. Additional information received as bearing damaged found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768578 ↗
• MalfunctionJun 25, 2026Vibration

  IT WAS REPORTED THAT DURING PRE OP, ATTACHMENT IS JUMPING. IT WAS REPORTED THAT 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 25618840 ↗
• MalfunctionJun 24, 2026Vibration

  IT WAS REPORTED THAT THE ATTACHMENT VIBRATED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604142 ↗
• MalfunctionJun 22, 2026Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DRILL WAS OVERHEATING AND ITS MAKING STRANGE NOISE PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579831 ↗
• MalfunctionJun 22, 2026Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT HAS OVERHEATING AND ITS MAKING STRANGE NOISE PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579297 ↗
• MalfunctionJun 22, 2026Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING AND MAKING NOISE PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573984 ↗
• MalfunctionJun 21, 2026Overheating of Device

  IT WAS REPORTED THAT DURING IN SERVICE, THE ATTACHMENT EXPERIENCED TEMPERATURE INCREASE. AT THE TIME OF EVENT, THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572302 ↗
• MalfunctionJun 19, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, BEARINGS ARE BAD. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25557267 ↗
• MalfunctionJun 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE-OP, BEARINGS BROKE. 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 25542561 ↗
• MalfunctionJun 17, 2026Naturally Worn

  IT WAS REPORTED THAT DURING INTRAOPERATIVE PROCEDURE, THE BEARINGS WERE INACCURATE. AT THE TIME OF EVENT, THERE IS NO PATIENT INVOLVEMENT AND IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534684 ↗
• MalfunctionJun 17, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529828 ↗
• MalfunctionJun 16, 2026Naturally Worn

  IT WAS REPORTED THAT DURING PRE-OP, THE ATTACHMENT HAD BEARINGS PROBLEM. IT WAS REPORTED 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 25517827 ↗
• MalfunctionJun 12, 2026Naturally Worn

  IT WAS REPORTED THAT BEARINGS ARE WORN. AT THE TIME OR REPORT, THERE IS NO KNOWN IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486968 ↗
• MalfunctionJun 1, 2026Overheating of Device

  IT WAS REPORTED THAT DURING SERVICING, THE ATTACHMENT EXPERIENCED A TEMPERATURE INCREASE. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349719 ↗
• MalfunctionMay 19, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING FALLOUT AT TUBE DISTAL THAT CAUSES RATTLING SOUND WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212711 ↗
• MalfunctionApr 12, 2022Overheating of Device; Vibration; Naturally Worn; Overheating of Device; Vibration; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BEARINGS CHATTER. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON EVALUATION DETERMINED THAT DEVICE WAS OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14080871 ↗