Midas Rex MR8 MR8-AVA14-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000063825), received between Aug 28, 2024 and Aug 27, 2026 — classified as 10 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 18, 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.

• MalfunctionAug 27, 2026Overheating of Device

  It was reported that the device had a temperature increase during field service. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50478835 ↗
• MalfunctionJun 23, 2026Difficult to Insert

  IT WAS REPORTED THAT THERE WAS DIFFICULTY INSERTING TOOL/BLADE INTO THE ATTACHMENT PRE-OPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25594280 ↗
• 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 25499298 ↗
• MalfunctionJun 15, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF CABLE DAMAGED. 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 25498264 ↗
• MalfunctionMay 25, 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 BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270486 ↗
• MalfunctionApr 16, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE THERE WAS DIFFICULTY IN LOCKING THE BURR. THERE WAS NO PATIENT IMPACT IN THIS EVENT.ADDITIONAL INFORMATION RECEIVED STATING THAT THE BEARINGS WERE MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24892900 ↗
• MalfunctionSep 10, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012812 ↗
• MalfunctionMay 29, 2025Overheating of Device; Overheating of Device

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104000 ↗
• MalfunctionSep 9, 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 20168238 ↗
• MalfunctionAug 28, 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 REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085605 ↗