Midas Rex MR8 MR8-AA14-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000063443), received between Aug 9, 2024 and Jun 16, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 25516875 ↗
• MalfunctionJun 15, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501432 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING THE PROCEDURE. IT WAS REPORTED THAT 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 25499090 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT DURING MAINTENANCE, ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498215 ↗
• MalfunctionJun 11, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHEMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466463 ↗
• MalfunctionApr 30, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT A DEVICE HAD A TEMPERATURE INCREASE INTRA-OPERATIVELY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS A SPINE PROCEDURE AND WAS COMPLETED WITH A BACKUP PRODUCT WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045993 ↗
• MalfunctionNov 10, 2025Corroded; Overheating of Device; Corroded; Overheating of Device

  IT WAS REPORTED THAT THE END OF THE ATTACHMENT HAS QUITE A BIT OF CORROSION AND EXPERIENCED OVERHEATING PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507763 ↗
• MalfunctionMar 24, 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 21675203 ↗
• MalfunctionMar 24, 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 21675007 ↗
• MalfunctionMar 17, 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 21616843 ↗
• 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 21561839 ↗
• MalfunctionFeb 24, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447101 ↗
• MalfunctionNov 28, 2024Overheating 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. 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 20805063 ↗
• MalfunctionAug 9, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DRUING THE SURGERY THE DOCTOR'S HAND HAD BURNS DUE TO DEVICE OVERHEATING. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947789 ↗