Midas Rex MR8 MR8-AF03 (UDI 00643169912410)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169912410), received between Jul 29, 2022 and Sep 10, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Detachment of Device or Device Component

  It was reported that the ball bearings fell out from the device. There was no patient involvement and patient impact in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50705941 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER TURNING FLAP THE ATTACHMENT WAS REMOVED AND FELL OUT AND PARTS WERE ALL RETRIEVED BUT CAME UP MISSING AFTER BEING TRANSPORTED TO BIOMEDICAL ENGINEERING. IT WAS ALSO REPORTED THAT THERE WAS NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY AND PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875502 ↗
• MalfunctionJul 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF FOOT OF THE ATTACHMENT WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. DATE OF EVENT NOTIFIED: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131102 ↗