MIDAS REX EM200 (UDI 00721902573613)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902573613), received between Jun 18, 2025 and Aug 22, 2025 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING.NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22870711 ↗
• MalfunctionJun 18, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22271167 ↗