MIDAS REX MR8 MR8-AVA14 (UDI 00763000441302)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00763000441302), received between Aug 20, 2024 and Sep 30, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (13 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Remove

  It was reported that the attachment was stuck in the motor. At the time of the report, there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943375 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DRILL ATTACHMENT IS DEFECTIVE. 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 25716269 ↗
• MalfunctionJul 3, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT DOES NOT WORK PROPERLY. 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 25703833 ↗
• MalfunctionJul 2, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DISTAL BEARING IS MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686717 ↗
• MalfunctionJul 1, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675073 ↗
• MalfunctionJun 22, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE IS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573439 ↗
• MalfunctionJun 17, 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 25534696 ↗
• MalfunctionJun 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ATTACHMENT WAS DEFECTIVE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494739 ↗
• MalfunctionJun 10, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER HAD GENERAL DISSATISFACTION OVER THE PRODUCT. THERE WAS NO IMPACT TO THE PATIENT AT THE TIME OF REPORT. ADDITIONAL INFORMATION RECEIVED AS DETACHED BEARING FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453042 ↗
• MalfunctionJun 8, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WITH OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426488 ↗
• MalfunctionMay 15, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING TESTING THE ATTACHMENT DIDN'T LOCK THE BURR. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183286 ↗
• MalfunctionMay 12, 2026No Apparent Adverse Event

  IT WAS REPORTED WITH THE REPORT OF GENERAL DISSATISFACTION. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DISTAL BEARING IS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146414 ↗
• MalfunctionApr 29, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. NO PATIENT IMPACT OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25030500 ↗
• MalfunctionApr 27, 2026Overheating of Device; Vibration

  IT WAS REPORTED THAT DURING USE, ATTACHMENT WAS EXCESSIVELY VIBRATING AND OVERHEATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002205 ↗
• MalfunctionApr 19, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT CUSTOMER HAD ISSUE WITH THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS WERE DETACHED FOUND IN ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921386 ↗
• MalfunctionApr 6, 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 24787451 ↗
• MalfunctionApr 1, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WAS IDENTIFIED AS DEFECTIVE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24751074 ↗
• MalfunctionMar 21, 2026Overheating of Device

  IT WAS REPORTED THAT DURING TESTING THE ATTACHMENT WITH THE REPORT OF TEMPERATURE INCREASE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656600 ↗
• MalfunctionNov 19, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590543 ↗
• MalfunctionSep 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT A COMPLAINT .NO PATIENT IMPACT REPORTED.REPAIR REQUEST ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHMENT OF COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 23008179 ↗
• MalfunctionMar 19, 2025Overheating of Device; Overheating of Device

  ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643181 ↗
• MalfunctionMar 19, 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 21642303 ↗
• MalfunctionMar 11, 2025Overheating of Device; Difficult to Remove; Overheating of Device; Difficult to Remove

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND REMOVAL DIFFICULTY. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21571747 ↗
• MalfunctionSep 26, 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 CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20317111 ↗
• MalfunctionSep 20, 2024Difficult to Insert; Difficult to Insert

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EARLY FAILURE THAT IS LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266478 ↗