MIDAS REX MR8 MR8-AVS12 (UDI 00763000441388)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000441388), received between Jul 9, 2025 and Sep 28, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  It was reported that the attachment was locked/sleeve-sticking. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912005 ↗
• MalfunctionSep 27, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910425 ↗
• MalfunctionSep 25, 2026Difficult to Remove

  It was reported that the attachment was blocked. At the time of report, there was no patient or staff impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893951 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. There was no patient i mpact as a result of the event. Additional information was received stating that bearing fallout at tube distal was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886192 ↗
• MalfunctionSep 24, 2026Overheating of Device

  It was reported that during use, the attachment was overheating. It was reported that there was no patient impact. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885872 ↗
• MalfunctionJun 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE THE BALL BEARING FAILURE AND FALLING OUT OF ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662593 ↗
• MalfunctionMay 21, 2026Naturally Worn

  IT WAS REPORTED THAT, WHILE PREPARING FOR USE, THE BEARINGS WERE FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25238990 ↗
• MalfunctionApr 28, 2026Difficult to Insert; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS LOOSE BALL BEARINGS AND UNABLE TO SEAT THE BURR. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION CONFIRMED THE LOOSE BALL BEARING MADE THIS EVENT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010848 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564114 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BEARING DETACHMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22454784 ↗