MIDAS REX MR8 MR8-AF03 (UDI 00763000441029)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000441029), received between Nov 10, 2023 and Sep 29, 2026 — classified as 10 malfunctions.

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

• MalfunctionSep 29, 2026No Apparent Adverse Event

  It was reported that the attachment with the report of no reported issue. 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 50927587 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. There was no patient involved. Additional information was received stating that the bearing was misaligned, which was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911858 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  It was reported that there was no alleged issue at the time of intake. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911138 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895876 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885675 ↗
• MalfunctionSep 23, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. There was no patient impact. Additional information was received stating that misaligned distal bearing was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865056 ↗
• MalfunctionJun 12, 2026Overheating of Device

  IT WAS REPORTED THAT OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491245 ↗
• MalfunctionJun 5, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25407977 ↗
• MalfunctionJun 5, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25407794 ↗
• MalfunctionNov 10, 2023Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF DETACHED FOOT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116875 ↗