Midas Rex EM100-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00763000096632), received between Sep 24, 2019 and Mar 10, 2025 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (28 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557855 ↗
• MalfunctionMar 3, 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 21501917 ↗
• MalfunctionFeb 25, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456260 ↗
• MalfunctionFeb 7, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THE REPAIR REQUEST WAS ESCALATED TO A PRODUCT EVENT DUE TO THE RETURN OF THE PART IN LESS THAN 90 DAYS FROM THE PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332158 ↗
• MalfunctionFeb 7, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331531 ↗
• MalfunctionDec 4, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. 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 20843385 ↗
• MalfunctionOct 17, 2024Loss of Power; Loss of Power

  IT WAS REPORTED THAT HANDPIECE IS FAULTY AND MOTOR DOESN'T WORK. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469529 ↗
• MalfunctionAug 22, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.  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 20024431 ↗
• MalfunctionMay 28, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403206 ↗
• MalfunctionApr 20, 2023Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT WAS REPORTED. REPAIR ESCALATED TO A PRODUCT EVENT ON EVALUATION FINDINGS OF OVERHEATING. ON FOLLOW UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776150 ↗
• MalfunctionMar 15, 2023Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16543606 ↗
• MalfunctionFeb 14, 2023Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO REASON FOR RETURN. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16370397 ↗
• MalfunctionNov 21, 2022Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN. ON FOLLOW UP NO PATIENT ADDITIONAL DETAILS ARE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15832836 ↗
• MalfunctionAug 23, 2022Unintended System Motion; Overheating of Device; Unintended System Motion; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF RUNS UNINTENTIONALLY AND OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. DATE OF EVENT NOTIFICATION (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274535 ↗
• MalfunctionAug 22, 2022Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DEVICE OVERHEATING. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY. DATE OF EVENT NOTIFIED ON (B)(6)2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265222 ↗
• MalfunctionJul 5, 2022Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO A PRODUCT EVENT DUE TO REASON FOR RETURN. DATE OF EVENT NOTIFICATION : 2022-APRIL-11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14913647 ↗
• MalfunctionMay 30, 2022Misconnection; Overheating of Device; Misconnection; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND LOCK NOT WORKING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. 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 14540192 ↗
• MalfunctionMay 18, 2022Overheating of Device; Device Remains Activated; Overheating of Device; Device Remains Activated

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND RUNS UNINTENTIONALLY. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY. DATE OF NOTIFICATION: 28-MAR-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432400 ↗
• MalfunctionApr 25, 2022Overheating of Device; Detachment of Device or Device Component; Overheating of Device; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHED COMPONENT . IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196409 ↗
• MalfunctionApr 12, 2022Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT WORKING. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO A PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14081285 ↗
• MalfunctionMar 17, 2022Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF SEIZED. NO PATIENT IMPACT WAS REPORTED. REPAIR ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796810 ↗
• MalfunctionMar 9, 2022Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING . NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ON FURTHER FOLLOW-UP, NO INFORMATION WAS PROVIDED REGARDING THE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13708979 ↗
• InjuryNov 29, 2021Overheating of Device; Overheating of Device

  ON FURTHER FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883233 ↗
• MalfunctionSep 9, 2021Overheating of Device; Device Displays Incorrect Message; Physical Resistance/Sticking; Overheating of Device; Device Displays Incorrect Message; Physical Resistance/Sticking

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ERROR CODE AND STICKING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND DUE TO EVALUATION FINDINGS OF OVERHEATING. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451117 ↗
• MalfunctionJun 18, 2021Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND DUE TO EARLY FAILURE (<(><<)>90).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12023554 ↗