MIDAS REX MR8 MR8-AVS09 (UDI 00763000441364)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000441364), received between Nov 14, 2024 and May 12, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Loss of Power” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO USE THE TOOL OR BLADE NOT LOCKING. AT THE TIME OF THE REPORT, THERE WAS NO IMPACT TO THE PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146808 ↗
• MalfunctionMay 4, 2026Loss of Power

  IT WAS REPORTED THAT THE DEVICE WOULD NOT TURN PRE-OPERATIVELY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071041 ↗
• MalfunctionMar 26, 2026Overheating of Device

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

  Patient problems: Insufficient Information

  MAUDE report 24697369 ↗
• MalfunctionAug 13, 2025Overheating of Device; Loss of Power; Overheating of Device; Loss of Power

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE BLUE HANDPIECE (INTENDED FOR USE WITH ROUND BURRS) DID NOT ALLOW PROPER DRILLING. THE BURR WAS EITHER SPINNING FREELY OR NOT SPINNING AT ALL, RESULTING IN INEFFICIENT DRILLING. SHORTLY AFTER INITIATION, THE HANDPIECE BEGAN TO OVERHEAT WITHOUT PERFORMING ANY EFFECTIVE CUTTING. THE ISSUE OCCURRED WHILE THE SURGEON WAS WORKING NEAR A SINUS AND REQUIRED PRECISE CONTROL; HOWEVER, DUE TO THE MALFUNCTION, ADDITIONAL PRESSURE HAD TO BE APPLIED TO ACHIEVE MINIMAL DRILLING. THE DEVICE WAS REPLACED WITH A BACKUP MOTOR AND BLUE HANDPIECE ALONG WITH A NEW BURR, WHICH FUNCTIONED AS EXPECTED AND ALLOWED THE PROCEDURE TO CONTINUE WITHOUT FURTHER ISSUES. IT WAS ALSO REPORTED THAT INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THE EVENT RESULTED IN A PROCEDURAL DELAY OF APPROXIMATELY 5 MINUTES. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791052 ↗
• MalfunctionNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BEARING DETACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT 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 20680361 ↗