MIDAS REX MR8 MR8-AS12Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000441067), received between Mar 13, 2025 and Aug 27, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. At the time of report no patient impact is been observed. Additional information received stating that damaged bearing at tube distal were found during evaluation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50470520 ↗
• MalfunctionJun 23, 2026Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, ATTACHMENT WAS NOT ATTACHING TO DRILL. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25589816 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MOTOR WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ON FOLLOW-UP, IT WAS ALSO REPORTED THAT THERE WAS ONLY A DELAY IN SURGERY DUE TO NEEDING TO REPLACE THE ATTACHMENT, LESS THAN 30 MINS.

  Patient problems: Insufficient Information

  MAUDE report 25529254 ↗
• MalfunctionJun 5, 2026Overheating of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT BEARING WAS DETACHED AND WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404120 ↗
• MalfunctionJun 4, 2026Overheating of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT BEARING WAS MISSING AND WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25388264 ↗
• MalfunctionMay 26, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD ITS BEARING GONE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25274902 ↗
• MalfunctionMar 13, 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 21595565 ↗