Midas Rex® EF201 (UDI 00643169931497)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169931497), received between Jul 1, 2021 and May 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING POSTERIOR SPINE FUSION PROCEDURE, FOOT CONTROL WAS RUNNING CONTINUOUSLY. PROCEDURE WAS COMPLETED WITH A DIFFERENT FOOT PEDAL. DEVICE WAS WORKING WHEN FIRST PLUGGED INTO IPC. WHEN THE USER STEPPED OFF THE FOOT PEDAL, THE DRILL KEPT RUNNING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010918 ↗
• MalfunctionApr 4, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT INTRAOPERATIVE, HAND CONTROL HAND PIECE ONLY ACTIVATES FROM FOOT PEDAL. HAND PIECE WAS IN SAFE MODE ACTIVE BY FOOT PEDAL. FOOT CONTROL STARTED RUNNING CONTINUOUSLY. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770626 ↗
• MalfunctionNov 23, 2022Device Remains Activated; Device Remains Activated

  HEALTH CARE PROFESSIONAL REPORTED THAT THE FOOT CONTROL RUNS CONTINUOUSLY. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15856361 ↗
• MalfunctionJul 1, 2021Self-Activation or Keying; Self-Activation or Keying

  UPON FURTHER FOLLOW UP IT WAS CONFIRMED BY HCP THAT NO ONE HAD BEEN USING THE HANDPIECE AND FOOT PEDAL, AND ALL OF A SUDDEN THE DRILL STARTED RUNNING ALL ON ITS OWN AT LOW SPEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12101041 ↗