Midas Rex MR8 MR8-AS07 (UDI 00643169912229)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00643169912229), received between Aug 24, 2023 and Sep 27, 2026 — classified as 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (24 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910085 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. At the time of the report, there was no known impact to the patient.

  Patient problems: Insufficient Information

  MAUDE report 50894332 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. There was no patient impact in this event. Additional information received on evaluation that bearings were misaligned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879937 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component; Naturally Worn; No Apparent Adverse Event

  It was reported that the device was broken. At the time of the event, there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684126 ↗
• MalfunctionAug 17, 2026Loss of Power

  It was reported that the attachment with the report of loss of power. 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 50269771 ↗
• MalfunctionAug 11, 2026Overheating of Device; Vibration

  It was reported that attachment was vibrating, powder leaking and smells like burned. It was reported that there was no patient or staff impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50210841 ↗
• MalfunctionJul 6, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE BEARINGS FAILED. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING FALLOUT AT TUBE DISTAL WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713618 ↗
• MalfunctionJul 4, 2026Overheating of Device; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WAS BROKEN AND BURNED. AT THE TIME OF EVENT, THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25709729 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING PRIOR TO USE THE ATTACHMENT WAS FOUND NOT WORKING. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED ON EVALUATION STATED THAT DISTAL BEARING WERE DETACHED MADE THIS EVENT REPORTABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688042 ↗
• MalfunctionJul 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PARTS DETACHED OR MISSING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED STATING THAT PRIOR TO USE THE BEARINGS ARE DETACHED OR MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675486 ↗
• MalfunctionJun 23, 2026Naturally Worn

  IT WAS REPORTED THAT THERE WAS SHORT YELLOW TIP. 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 25590136 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT BEARINGS DROPPED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529887 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PRE-OP FROM THE ATTACHMENT BEARING WAS DROPPED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529487 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BEARING WAS DROPPED PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528271 ↗
• MalfunctionJun 16, 2026Naturally Worn

  IT WAS REPORTED THAT THE BEARINGS IN THE ATTACHMENT FAILED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514119 ↗
• MalfunctionJun 16, 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 WAS INVOLVED . ADDITIONAL INFORMATION RECEIVED THAT BEARINGS WERE DETACHED DURING THE EVALUATION .

  Patient problems: Insufficient Information

  MAUDE report 25514059 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF OVERHEATING. 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 25499128 ↗
• MalfunctionJun 15, 2026Vibration

  IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT REPORTED WITH ISSUE OF CHATTER. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498828 ↗
• MalfunctionJun 15, 2026Vibration

  IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT REPORTED WITH THE ISSUE OF CHATTER. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498750 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT DURING MAINTENANCE, ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498238 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT HAD BALL BEARING FELL OUT/MISSING . AT THE TIME OF EVENT, THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470440 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A BALL BEARING FELL OUT AND WAS MISSING. IT WAS REPORTED THAT THERE IS NO PATIENT INVOLVEMENT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453074 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT'S BALL BEARING FELL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452874 ↗
• MalfunctionJun 10, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE PROCEDURE THE DEVICE DOES NOT RETAIN THE TOOL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT IMPACT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION THAT THE BEARINGS WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452515 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WITH BALL BEARING FELL OUT/MISSING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444845 ↗