Midas Rex MR8 MR8-AVA12DK (UDI 00643169975262)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169975262), received between Jun 23, 2021 and Jun 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A CASE, THE DEVICE WAS OVERHEATING. IT WAS ALSO REPORTED THAT A 12MH30 TOOL WAS USED WITH THE ATTACHMENT. NO PATIENT IMPACT WAS REPORTED. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT. IT WAS ALSO REPORTED THAT THERE WAS NO ISSUE WITH TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050877 ↗