Bovie AA21Recalls & reported problems
Aspen Surgical Products, Inc. · CAUTERY HIGH TEMPERATURE ELONGATED TIP · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607151011215), received between Mar 16, 2023 and Aug 26, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Failure to Power Up1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
COMPLAINANT ALLEGES "FILAMENT ISSUE AND FELL APART. 3 INSTANCES OF NOTE TO DATE, HAPPENED DURING 3 DIFFERENT PROCEDURES.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22898122 ↗MalfunctionAug 26, 2025Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGES "THE DOCTOR WENT TO USE ONE OF THE CAUTERIZING PENS THIS MORNING AND IT'S COMPLETELY DEFECTIVE. THEY WEREN'T ABLE TO USE IT SO WE HAD TO OPEN UP ANOTHER ONE WHEN I GOT TO THE CLINIC."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22894409 ↗MalfunctionAug 15, 2024Break; Break
THE COMPLAINANT ALLEGES, "THE METAL TIP ON THE END OF THE CAUTERY HIGH TEMP TOOL IS VERY FLIMSY AND HAS BEEN BREAKING OFF (OR BURNING ITSELF OUT) DURING VASECTOMY PROCEDURES. HE HAS HAD TO USE 2 OR 3 ITEMS PER PROCEDURE, IN THE PAST ONE ITEM HAS BEEN USED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19996802 ↗MalfunctionMar 16, 2023Break; Break
DURING A VASECTOMY IT WAS NOTICED BY THE MD WHILE HEATING UP THAT THE WIRE SEPERATED FROM THE TIP AND WAS ON. IT WAS THEN REMOVED WITH NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16559250 ↗
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- Argent 231Mckesson Medical-Surgical Inc. · Unit, Cautery, Thermal, Battery-Powered3 reports
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- Argent 244Mckesson Medical-Surgical Inc. · Unit, Cautery, Thermal, Battery-Powered2 reports
- Bovie AA01XAspen Surgical Products, Inc. · Unit, Cautery, Thermal, Battery-Powered2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.