Bovie AA01XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607151008956), received between Mar 8, 2024 and Aug 9, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Overheating of Device; Overheating of Device

  THE COMPLAINANT ALLEGES THE AA01X WAS ABLE TO BE ACTIVATED WHILE THE CAP WAS ENGAGED; "REPLACED CAP AS ONE IS SUPPOSED TO DO BUT WASN'T AWARE THAT IT CAN EASILY PRESS THE OPERATING BUTTON DOWN AND KEEP THE BOVIE ON AND HOT. NOTED BY NURSE SEVERAL MINUTES LATER AS IT WAS STARTING TO MELT ON THE TRAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950129 ↗
• MalfunctionMar 8, 2024Break; Break

  THE COMPLAINANT ALLEGED, "WE WERE USING A PEN TIP CAUTERY TO RELEASE PRESSURE ON AN INJURED TOENAIL WHEN THE CAUTERY TIP BROKE ON 3 UNITS. THE 4TH UNIT WORKED WITHOUT BREAKING. ALL UNITS WERE THE SAME TYPE (REF#AA01X). THE PATIENT WAS NOT INJURED IN ANY WAY, IT JUST TOOK LONGER TO PERFORM THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866502 ↗