Midas Rex MR8 MR8-AVA07 (UDI 00643169912649)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169912649), received between Jun 21, 2024 and Aug 17, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50273849 ↗
• MalfunctionJul 4, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT IS ROLLING ISSUE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25709821 ↗
• MalfunctionJul 3, 2026Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE ADJUSTMENT RING BLOCKED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25706659 ↗
• MalfunctionJul 3, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING WHILE ON MOTOR. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701166 ↗
• MalfunctionJul 1, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675260 ↗
• MalfunctionJun 18, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE IS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25544974 ↗
• MalfunctionJun 10, 2026Difficult to Remove

  IT WAS REPORTED THAT ATTACHMENT WAS STUCK. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462913 ↗
• MalfunctionJun 5, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE IS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS BEARING DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25405416 ↗
• MalfunctionMay 20, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT INPUT AND OUTPUT DRIVE SHAT WAS CORRODED, BEARING INTERNAL TUBE IS DETACHED, TUBE BEARINGS ARE WORN AND COLOR RING AND LASER MARKINGS WERE FOUND FADED DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229065 ↗
• MalfunctionApr 17, 2026Loss of Power

  IT WAS REPORTED THAT THE HANDPIECE SEIZED. THERE WAS NO PATIENT IMPACT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED AFTER EVALUATION AS DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907070 ↗
• MalfunctionApr 1, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. AT THE TIME OF 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 24751718 ↗
• MalfunctionMar 18, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630666 ↗
• MalfunctionSep 18, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249193 ↗
• MalfunctionJun 21, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582408 ↗