Midas Rex® EF201RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169931503), received between May 16, 2023 and May 27, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (7 reports).

3 other recalls cover devices cleared under the same FDA submission (K081475); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT PREOPERATIVE, FOOT CONTROL STICKING AND RUNS CONTINUOUSLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22085407 ↗
• MalfunctionMay 12, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING INTRA OP THE PEDAL IS TURNING HANDPIECE ON WHEN FOOT IS NOT ON PEDAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001589 ↗
• MalfunctionOct 11, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT PRE-OP, THE FOOT CONTROL KEEPS RUNNING. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425139 ↗
• MalfunctionSep 24, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE RUNS CONTINUOUSLY EVEN WHEN NOT PRESSED. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297910 ↗
• MalfunctionOct 27, 2023Device Remains Activated; Use of Device Problem; Device Remains Activated; Use of Device Problem

  IT WAS REPORTED THAT THE FOOTSWITCH WAS NOT WORKING AND CAUSED THE DRILL TO CONSTANTLY RUN. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017895 ↗
• MalfunctionAug 11, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT HANDPIECE ACTIVATED WITHOUT PEDAL BEING PUSHED, THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510443 ↗
• MalfunctionMay 16, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT PRE-OP, DEVICE RUNS CONTINUOUSLY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936789 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081475. 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
• Z-0158-2022 · Aug 31, 2021 · Open, Classified
  Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with
• Z-2085-2016 · May 13, 2016 · Terminated
  Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: