Midas Rex MR8 MR8-AA10-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000063405), received between Jan 20, 2023 and Jul 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Overheating of Device

  It was reported that the attachment was overheating. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50066470 ↗
• MalfunctionJun 22, 2026Corroded

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) THERE WAS RUST/ CORROSION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25576931 ↗
• MalfunctionJun 22, 2026Corroded

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE THE DEVICE HAD RUST/CORROSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25576919 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25500217 ↗
• MalfunctionMay 25, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT ATTACHMENT STUCK ON MOTOR. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268132 ↗
• MalfunctionJun 9, 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 22173143 ↗
• MalfunctionApr 18, 2025Overheating 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863976 ↗
• MalfunctionMar 13, 2025Corroded; Detachment of Device or Device Component; Naturally Worn; Corroded; Detachment of Device or Device Component; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BEARING DETACHMENT AND CORROSION AND WORN. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21597449 ↗
• MalfunctionSep 23, 2024Overheating 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 OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281200 ↗
• MalfunctionApr 16, 2024Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114441 ↗
• MalfunctionJan 20, 2023Overheating 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 AND ALSO DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR. ON FOLLOW UP, IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213187 ↗