Midas Rex MR8 MR8-AA14 (UDI 00643169912373)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00643169912373), received between Aug 12, 2024 and Sep 24, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (23 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 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 bearing was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877363 ↗
• MalfunctionSep 16, 2026Overheating of Device; Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785020 ↗
• MalfunctionAug 26, 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 patient impact. Additional information was received stating that seized bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451748 ↗
• MalfunctionJul 2, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE THE DEVICE WAS GETTING HOT. AT THE TIME OF THE REPORT, THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED STATING MISALIGNED DISTAL BEARING WAS FOUND DURING EVALUATION MADE IT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688567 ↗
• MalfunctionJul 1, 2026Difficult to Insert

  IT WAS REPORTED THAT THE LOCK IS NOT WORKING FOR THE TOOL. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS R ECEIVED STATING THAT BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676180 ↗
• MalfunctionJun 27, 2026Overheating of Device

  IT WAS REPORTED THAT DURING TESTING THERE WAS TEMPERATURE INCREASE. AT THE TIME OF REPORT, THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25645970 ↗
• MalfunctionJun 16, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516226 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF OVERHEATING. 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 25515848 ↗
• MalfunctionJun 15, 2026Difficult to Insert; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT WAS OVERHEATING AND WAS NOT ATTACHING TO DRILL. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 25499071 ↗
• MalfunctionJun 12, 2026Overheating of Device

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482747 ↗
• MalfunctionJun 12, 2026Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT LOCKING WAS ISSUE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING BROKEN WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482655 ↗
• MalfunctionJun 11, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING AND WOULD NOT POWER ON PRIOR TO A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472397 ↗
• MalfunctionJun 9, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WITH HEATING UP. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25445696 ↗
• MalfunctionJun 9, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT LOCK MECHANISM DOES NOT ROTATE PROPERLY, AND THE INTERNAL BALL BEARING IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439873 ↗
• MalfunctionMay 28, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT GOT FROZEN. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED INDICATES THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315372 ↗
• MalfunctionMay 21, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ENTRY WAS BLOCKED AND TOOL DIFFICULT TO INSERT DURING SERVICING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING WAS DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239792 ↗
• MalfunctionApr 27, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION ON EVALUATION DETACHMENT OF BEARING IS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25006172 ↗
• MalfunctionApr 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT WAS STICKING. AT THE TIME OF REPORT, THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921062 ↗
• MalfunctionApr 3, 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: Insufficient Information

  MAUDE report 24777355 ↗
• MalfunctionMar 25, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE IS OVERHEATING. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24688667 ↗
• MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST WAS INITIATED FOR A 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 23297040 ↗
• MalfunctionJun 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED WITH THE REPORT OF NO ALLEGED ISSUE. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING. ON FOLLOWUP NO ADDITIONAL INFORMATION WAS PROVIDED ABOUT THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22182783 ↗
• MalfunctionMar 19, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641599 ↗
• MalfunctionMar 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 OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557325 ↗
• MalfunctionMar 7, 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 21549090 ↗