MIDAS REX MR8 MR8-AS15 (UDI 00763000441081)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000441081), received between Mar 4, 2026 and Sep 28, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026No Apparent Adverse Event

  Medtronic received information regarding a preventive maintenance, and no alleged product deficiencies were reported. At the time of report there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910729 ↗
• MalfunctionSep 16, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788615 ↗
• MalfunctionJul 3, 2026Difficult to Insert

  IT WAS REPORTED THAT, PRIOR TO AN OPERATION, THE ATTACHMENT HAD DIFFICULTY INSERTING. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING WAS MISALINGED DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700920 ↗
• MalfunctionJun 25, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621576 ↗
• MalfunctionJun 24, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25606523 ↗
• MalfunctionJun 24, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE NOT WORKING PROPERLY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DAMAGE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604453 ↗
• MalfunctionJun 24, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604023 ↗
• MalfunctionJun 24, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DAMAGE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604005 ↗
• MalfunctionJun 24, 2026Overheating of Device

  IT WAS REPORTED THAT 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 25603697 ↗
• MalfunctionJun 23, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF TEMPERATURE INCREASE.  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 25591861 ↗
• MalfunctionJun 22, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DAMAGED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573168 ↗
• MalfunctionJun 19, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS BEARING ISSUE PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25558732 ↗
• MalfunctionJun 19, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25556551 ↗
• MalfunctionJun 18, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DAMAGE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542977 ↗
• MalfunctionJun 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF NO REPORTED ISSUE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS BROKEN WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534848 ↗
• MalfunctionJun 9, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT HAD BEARING PROBLEM. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444250 ↗
• MalfunctionApr 28, 2026Overheating of Device

  IT WAS REPORTED THAT THE PRODUCTS WERE OVERHEATING DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT OR CASE DELAY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010866 ↗
• MalfunctionMar 4, 2026Corroded

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF CORROSION. IT WAS REPORTED THAT THERE IS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT MISALIGNED DISTAL BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510723 ↗