Midas Rex® EF200 (UDI 00643169931473)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169931473), received between Apr 8, 2024 and Dec 16, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT FOOTCONTORL WAS NOT WORKING PROPERLY, NOT TURNING OFF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813126 ↗
• MalfunctionMay 18, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DEVICE RUNS CONTINUOUSLY, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041496 ↗
• MalfunctionApr 1, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED DURING POST-OP THAT THE DEVICE HAD RUN CONTINUOUSLY ON ITS OWN WITHOUT SURGEON INTERACTION 10 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21736770 ↗
• MalfunctionOct 19, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DRIVE CONNECTED TO THE CONSOLE BY ITSELF STARTS WORKING (SAME DRIVE ON ANOTHER CONSOLE WORKS NORMALLY). THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488949 ↗
• MalfunctionAug 8, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DEVICE ACTIVATES EVEN WHEN NOT BEING PUSHED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19936141 ↗
• MalfunctionApr 8, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING PROCEDURE FOOT CONTROL GETS STUCK AND CONSEQUENTLY CANNOT STOP THE DRILL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057307 ↗