MIDAS REX MR8 MR8-AF01 (UDI 00763000440985)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00763000440985), received between Dec 19, 2025 and Sep 30, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. There was no patient impact reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943837 ↗
• MalfunctionSep 27, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910396 ↗
• MalfunctionSep 25, 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 was observed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894800 ↗
• MalfunctionSep 24, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885886 ↗
• MalfunctionSep 24, 2026Material Deformation

  It was reported that during testing, the markings on the attachment noted to be damaged and illegible. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881786 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that two small ring fell from the inside of attachment after use. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863715 ↗
• 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 the bearings were ruptured.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863435 ↗
• MalfunctionSep 10, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716444 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716263 ↗
• MalfunctionAug 21, 2026Detachment of Device or Device Component; Naturally Worn

  It was reported that prior to use, the attachment had a bearing issue. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50361120 ↗
• MalfunctionAug 10, 2026Vibration

  It was reported that the attachment had vibration. It was reported there was no patient involvement. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50190041 ↗
• MalfunctionJul 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SMALL PIECES FELL OFF THE PRODUCT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676500 ↗
• MalfunctionJun 18, 2026Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT DURING PRE-OP THE ATTACHMENT HAD BEARING ISSUE AND FOOT SLIGHTLY BENDED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549067 ↗
• MalfunctionJun 18, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS NO ALLEGED PRODUCT DEFICIENCY. AT THE TIME OF REPORT, THE IMPACT TO THE PATIENT WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25542569 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT THE DURING TESTING ATTACHMENT WAS OVERHEATING. IT WAS REPORTED 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 25515227 ↗
• MalfunctionJun 11, 2026Naturally Worn

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE THE BEARINGS WERE RUNNING ROUGH. THERE WAS NO PATIENT IMPACT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION THAT THE BEARINGS WERE MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466272 ↗
• MalfunctionMay 18, 2026Corroded

  IT WAS REPORTED THAT DURING IN-SERVICE THE DEVICE'S BEARING HAD RUST OR CORROSION ON IT. THERE WAS NO PATIENT INVOLVEMENT DURING THE TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209118 ↗
• MalfunctionApr 29, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS SENT IN WITH NO REPORTED ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE ANALYSIS FINDINGS.

  Patient problems: Insufficient Information

  MAUDE report 25031555 ↗
• MalfunctionApr 10, 2026Corroded

  IT WAS REPORTED THAT DURING IN-SERVICE THE RUST AND CORROSION WERE OBSERVED. AT THE TIME OF REPORT 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 24838187 ↗
• MalfunctionApr 6, 2026Overheating of Device

  IT WAS REPORTED THAT DURING PRE OPERATION THE ATTACHMENT HAD TEMPERATURE INCREASE. THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT MISALIGNED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796097 ↗
• MalfunctionApr 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BEARINGS DROPPED FROM THE ATTACHMENT PRIOR TO USE. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754491 ↗
• MalfunctionMar 31, 2026Overheating of Device

  IT WAS REPORTED THAT PRE-OPERATIVELY THE ATTACHMENT HAD A TEMPERATURE INCREASE OR WAS RUNNING HOT. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745551 ↗
• MalfunctionMar 31, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT HAD TEMPERATURE INCREASE PRE-OPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745320 ↗
• MalfunctionMar 31, 2026Overheating of Device

  IT WAS REPORTED THAT THERE WAS TEMPERATURE INCREASE PRE-OPERATIVELY. NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745052 ↗
• MalfunctionDec 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT FOOT BENT FOR THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847083 ↗