MIDAS REX MR8 MR8-AA14 (UDI 00763000440886)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00763000440886), received between Aug 9, 2024 and Sep 4, 2026 — classified as 1 injury, 63 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (34 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 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Overheating of Device

  It was reported that during pre-operative preparation for use, temperature increase was observed in the device. There was no patient impact in this event. Additional information received on evaluation that the bearings were misaligned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50606302 ↗
• MalfunctionAug 27, 2026No Apparent Adverse Event

  It was reported that the customer had general dissatisfaction over the product. There was no impact to the patient. Additional information received as bearings detached found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50470521 ↗
• MalfunctionJul 6, 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 25713586 ↗
• MalfunctionJul 3, 2026Overheating of Device

  IT WAS REPORTED THAT DURING SERVICING TEMPERATURE INCREASE WAS OBSERVED IN THE DEVICE. THERE WAS NO PATIENT IMPACT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION THAT BEARINGS WERE MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701065 ↗
• MalfunctionJul 3, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WERE NO ALLEGED ISSUE WITH THE DEVICE. 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 25700840 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS NO ALLEGED ISSUE AT THE TIME OF INTAKE. 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 25692003 ↗
• MalfunctionJul 2, 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 THE DETACHED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688872 ↗
• MalfunctionJul 1, 2026Loss of Power

  IT WAS REPORTED THAT THE DEVICE WAS SEIZED UP , AND CAN'T MOVE .AT THE TIME OF REPORT NO PATIENT IMPACT IS BEEN OBSERVED . ADDITIONAL INFORMATION RECEIVED THAT THE DISTAL BEARINGS WERE DETACHED DURING EVALUATION .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676295 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED 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 25667093 ↗
• MalfunctionJun 30, 2026Naturally Worn

  IT WAS REPORTED THAT THERE WAS A BEARING ISSUE IN THE ATTACHMENT. AT THE TIME OF THE REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665461 ↗
• MalfunctionJun 25, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF NO REPORTED ISSUE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617223 ↗
• MalfunctionJun 24, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS FOUND TO BE DEFECTIVE. AT THE TIME OF REPORT, THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607896 ↗
• MalfunctionJun 23, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25590747 ↗
• MalfunctionJun 22, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT ATTACHMENT LOCK/ SLEEVE STUCK OR STICKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25574051 ↗
• MalfunctionJun 21, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING SERVICING, THE TOOLS ARE NOT LOCKING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572308 ↗
• MalfunctionJun 21, 2026Overheating of Device

  IT REPORTED THAT OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25571895 ↗
• MalfunctionJun 18, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE, THE TOOL EXHIBITED A LOCKING ISSUE AND WAS DIFFICULT TO INSERT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25543401 ↗
• MalfunctionJun 18, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE THE DEVICE WAS GETTING HOT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DISTAL BEARINGS WERE MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542974 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT THERE WAS TEMPERATURE INCREASE INTRA-OPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519849 ↗
• MalfunctionJun 15, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25508245 ↗
• MalfunctionJun 15, 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 25498622 ↗
• MalfunctionJun 12, 2026Difficult to Insert

  IT WAS REPORTED THAT, PRIOR TO USE, THERE WERE MULTIPLE ISSUES WITH THE TOOL, INCLUDING A TOOL LOCKING ISSUE, DIFFICULTY INSERTING THE TOOL, THE ATTACHMENT LOCK OR SLEEVE BEING STUCK OR STICKING. NO PATIENT WAS INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481465 ↗
• MalfunctionJun 11, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THAT PRIOR TO USE, ATTACHMENT WAS NOT LOCKING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472769 ↗
• MalfunctionJun 11, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING PROCEDURE ATTACHMENT HAD A TOOL LOCKING ISSUE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25471965 ↗
• MalfunctionJun 8, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS EXPERIENCING OVERHEATING. AT THE TIME OF EVENT, THERE IS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT BEARINGS WERE DETACHED DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425050 ↗