MIDAS REX MR8 MR8-AVA12DK (UDI 00763000441296)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000441296), received between May 13, 2025 and Jun 8, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Overheating of Device

  IT WAS REPORTED THAT DEVICE, OVERHEATING. IT WAS REPORTED THAT THERE WERE NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25422978 ↗
• MalfunctionMay 26, 2026Device Reprocessing Problem

  IT WAS REPORTED THAT, PRIOR TO USE, THE ATTACHMENT WAS FOUND TO HAVE DEBRIS INSIDE. THERE WAS NO PATIENT IMPACT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273736 ↗
• MalfunctionMay 19, 2026Difficult to Insert

  IT WAS REPORTED THAT ATTACHMENT LOCKING MECHANISM WOULD NOT SECURE BURRS. IT WAS REPORTED THAT NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212240 ↗
• MalfunctionMay 13, 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 22010934 ↗