Midas Rex® EF200 (UDI 00613994384072)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994384072), received between Jan 31, 2017 and May 2, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT PRE-OP, THE FOOT SWITCH WAS RUNNING WITHOUT PRESSING THE PADDLE. THE DEVICE RAN IMMEDIATELY AFTER PLUGGING INTO THE SOURCE. THE DEVICE WAS AT REST AND TURNED ON IT BY ITSELF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947592 ↗
• MalfunctionApr 17, 2025Device Remains Activated; Device Remains Activated

  ADDITIONAL INFORMATION RECEIVED: THE DEVICE DID NOT ACTIVATE IMMEDIATELY WITH IPC. THE DEVICE IN USE, AND WHEN THE USER TRIED TO DISCONTINUE USE, THE ATTACHMENT KEPT RUNNING. THE DEVICE DID NOT RUN TURN ON BY SELF AFTER AT REST//INACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857874 ↗
• MalfunctionJan 13, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE IPC FOOT SWITCH DOES NOT STOP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21135380 ↗
• MalfunctionSep 3, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT AFTER TURNING ON DRIVE CONTINUOUSLY WORKS, DOES NOT TURNS OFF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20123121 ↗
• MalfunctionAug 9, 2023Device Remains Activated; Device Remains Activated

  INITIALLY THE INFORMATION RECEIVED WAS CONTRADICTING. NOW WE HAVE INFORMATION THAT THE EVENT MEETS RUN-ON CONDITION WHICH MEETS THE 'NO' CRITERIA FOR REPORTABILITY. THEREFORE UNREPORTING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17486355 ↗
• MalfunctionOct 5, 2021Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA DISTRIBUTOR THAT THE FOOT CONTROL WAS OVERHEATING DURING USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12575785 ↗
• MalfunctionMay 11, 2021Device Remains Activated; Device Remains Activated

  A HEALTH CARE PROVIDER REPORTED THAT THE FOOT CONTROL RUNS WHEN NOT PRESSED, RPMS ALSO GOES UP AND DOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805738 ↗
• MalfunctionJan 31, 2017Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A CASE, THE HANDPIECE WAS SITTING ON THE TROLLEY AND SUDDENLY POWERED ON. THE STAFF CONFIRMED THAT THE FOOT CONTROL WAS NOT PRESSED. THE HANDPIECE FINALLY STOPPED WHEN UNPLUGGED. A REPLACEMENT HANDPIECE WAS PLUGGED IN, BUT WOULD NOT START, EVEN WHEN THE FOOT CONTROL WAS PRESSED. THE FOOT CONTROL WAS REPLACED, WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6290162 ↗