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Midas Rex MR8 MR8-ASMC14-RRecalls & reported problems

Medtronic Ps Medical, Inc. · ATT MR8-ASMC14-R MR8 14CM MTLCUT3.2MMRFB · Class 2

All models of Midas Rex MR8 (41)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000063702), received between Jun 16, 2026 and Sep 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Naturally Worn1
  • Overheating of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2026Overheating of Device

    It was reported that there was temperature increase pre-operatively. There was no patient impact.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50887245 ↗
  • MalfunctionJun 16, 2026Naturally Worn

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25515404 ↗

Other DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices

All DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices →

Sources and updates

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