Midas Rex MR8 MR8-AS10 (UDI 00643169912236)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169912236), received between Aug 28, 2024 and Sep 9, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696529 ↗
• MalfunctionSep 8, 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 detached bearing was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50662234 ↗
• MalfunctionJul 2, 2026Corroded

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25691919 ↗
• MalfunctionJun 25, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAS UNSPECIFIED FAULT, POSSIBLY RELATED TO THE BEARINGS PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT LOOSE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617783 ↗
• MalfunctionJun 23, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS A BEARING PROBLEM. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BROKEN BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591481 ↗
• MalfunctionJun 23, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591124 ↗
• MalfunctionJun 22, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED STATING BEARINGS WERE BROKEN WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573248 ↗
• MalfunctionJun 20, 2026Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THE BALL BEARINGS FELL OUT AND THE BEARINGS ARE BAD. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25569139 ↗
• MalfunctionJun 19, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT HAD LOCKING ISSUE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25557624 ↗
• MalfunctionJun 18, 2026Vibration

  IT WAS REPORTED THAT DURING AN INTRAOPERATIVE THE ATTACHMENT EXHIBITED CHATTER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25543266 ↗
• MalfunctionJun 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534303 ↗
• MalfunctionJun 17, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BEARING WAS ISSUE PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING BROKEN WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25528373 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25500352 ↗
• MalfunctionJun 11, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAD BEARING PROBLEM. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466710 ↗
• MalfunctionJun 10, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT. ADDITIONAL INFORMATION THE BEARINGS ARE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461406 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING POST-OP, THE ATTACHMENT HAD BEARING DETACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461268 ↗
• MalfunctionJun 10, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF LOSS OF POWER. 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 25453477 ↗
• MalfunctionJun 9, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452461 ↗
• 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 25446587 ↗
• MalfunctionJun 9, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WITH HEATING UP. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25446118 ↗
• MalfunctionJun 9, 2026Difficult to Insert

  IT WAS REPORTED THAT THE BUR COULD NOT BE INSERTED IN THE ATTACHMENT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25442013 ↗
• MalfunctionMay 28, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25313324 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT WAS BEARING WAS DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299574 ↗
• MalfunctionMay 27, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS BEARING ISSUE PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS WERE BROKEN FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299020 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT IN THE ATTACHMENTS BEARING FELL OUT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25276184 ↗