MIDAS REX MR8 MR8-AVA12 (UDI 00763000441289)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000441289), received between Aug 20, 2024 and Jul 2, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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 16, 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.

• MalfunctionJul 2, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688095 ↗
• MalfunctionJul 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INSTALLATION A SMALL PART WAS FELL OUT. IT WAS REPORTED 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 25674879 ↗
• MalfunctionJun 18, 2026Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO USE, THE BUR WAS NOT SEATING ON THE ATTACHMENT. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545400 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT FROM THE ATTACHMENT PARTS FELL OUT. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: Insufficient Information

  MAUDE report 25516678 ↗
• MalfunctionJun 1, 2026Naturally Worn

  IT WAS REPORTED THAT THE DURING PREOP ATTACHMENT HAS BEARING PROBLEM. 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 25346455 ↗
• MalfunctionMay 15, 2026Loss of Power

  IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING DURING USE. 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 25182315 ↗
• MalfunctionMay 7, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF REPORT, THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113298 ↗
• MalfunctionMay 7, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111152 ↗
• MalfunctionMay 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT A COMPLAINT. NO PATIENT IMPACT REPORTED. THE EVENT ESCALATED TO PRODUCT EVENT AS EVALUATION CONFIRMED DETACHED BEARING.

  Patient problems: Insufficient Information

  MAUDE report 22084924 ↗
• MalfunctionApr 29, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924792 ↗
• MalfunctionMar 26, 2025Break; Overheating of Device; Break; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND BROKEN COMPONENT. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21694674 ↗
• MalfunctionSep 11, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN AND ALSO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193296 ↗
• MalfunctionSep 6, 2024Corroded; Overheating of Device; Corroded; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CORROSION AND OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162931 ↗
• MalfunctionSep 6, 2024Corroded; Overheating of Device; Corroded; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND CORROSION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN AND DUE TO EVALUATION DETERMINED DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155249 ↗
• MalfunctionSep 6, 2024Corroded; Overheating of Device; Corroded; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND CORROSION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154873 ↗
• MalfunctionAug 20, 2024Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PROBLEM NOT REPORTED. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002421 ↗