Midas Rex MR8 MR8-AVA10DK (UDI 00643169975248)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169975248), received between Oct 11, 2024 and Jun 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2026Difficult to Remove

  IT WAS REPORTED THAT ATTACHMENT IS STUCK DOES NOT WANT TO EXTEND. 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 25644930 ↗
• MalfunctionJun 16, 2026Corroded

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE THE DEVICE WAS CORRODED. THERE WAS NO PATIENT IMPACT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION THAT BEARINGS WERE SEIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515835 ↗
• MalfunctionJun 15, 2026Overheating of Device

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

  Patient problems: Insufficient Information

  MAUDE report 25500675 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499215 ↗
• MalfunctionJun 1, 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 DETACHED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354089 ↗
• MalfunctionApr 19, 2026Overheating of Device

  MEDTRONIC RECEIVED INFORMATION STATING THAT THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921072 ↗
• MalfunctionApr 10, 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 DISTAL BEARING DETACHMENT WAS FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842212 ↗
• MalfunctionApr 3, 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 INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781206 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE DEVICE WAS OBSERVED TO HAVE AN UNSCREWED HOUSING. 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 24660939 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BEARING DETACHMENT. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429380 ↗