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Midas Rex Clearview™ SP12MH25Recalls & reported problems

Medtronic Xomed, Inc. · TOOL DC SP12MH25 LGD 12CM PROX 2.5 MH · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169308527), received between Jan 18, 2018 and Jan 18, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081277); they may or may not involve this specific model.

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

Device problems

  • Overheating of Device1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 18, 2018Overheating of Device; Overheating of Device

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATES THE TOOL WAS BEING RUN AT 60,000 RPM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7203947 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.

  • Z-0961-2022 · Dec 15, 2021 · Terminated
    Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E

Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices

All DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page