Midas Rex PM700-R (UDI 00763000182052)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000182052), received between May 4, 2023 and Feb 19, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407709 ↗
• MalfunctionFeb 18, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400339 ↗
• MalfunctionFeb 18, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393314 ↗
• InjuryMay 4, 2023Electrical /Electronic Property Problem; Difficult to Remove; Electrical /Electronic Property Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING THE CRANIOTOMY PROCEDURE, THE BURR HOLES WERE DRILLED TO ACCESS THE BRAIN TUMOR USING THE MIDAS REX, USING A CODMAN 14MM DISPOSABLE PERFORATOR ATTACHMENT. FIRST BURR HOLE WAS DRILLED WITHOUT ANY INCIDENT, BUT THE DURING THE SECOND BURR HOLE THE ATTACHMENT GOT STUCK, WHILE LODGING THE PERFORATOR IN THE PATIENT'S SKULL. THE PERFORATOR COULD NOT BE MANUALLY REMOVED AND HAD TO BE CUT OUT. IT WAS ALSO REPORTED THAT INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). ON FOLLOW UP IT WAS REPORTED THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND THERE WAS A PROCEDURE DELAY APPROXIMATELY 45 MINUTES TO CALL UP ANOTHER DRILL. IT WAS ALSO REPORTED THAT AFTER OPERATION, THE CONDITION OF THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16866069 ↗