Midas Rex EM100-A-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000174842), received between Jan 11, 2019 and Mar 4, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST WAS INITIATED FOR THE 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 21512506 ↗
• MalfunctionMar 3, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505191 ↗
• MalfunctionFeb 25, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456769 ↗
• MalfunctionFeb 11, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT WAS REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN AND THE REPAIR AND RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354900 ↗
• MalfunctionJun 16, 2022Overheating 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 REASON FOR RETURN. DATE OF EVENT NOTIFICATION: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14710860 ↗
• MalfunctionJan 11, 2019Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8239256 ↗