Bovie AA03Recalls & reported problems
Aspen Surgical Products, Inc. · CAUTERY HIGH TEMPERATURE LOOP TIP · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607151011031), received between Jul 3, 2024 and Jul 8, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2025Fire; Fire
COMPLAINANT ALLEGES "AA03 CAUTERY CAUGHT FIRE AND CAUSED A SMALL BURN FOR THE PATIENT."
Patient problems: Superficial (First Degree) Burn
MAUDE report 22437895 ↗MalfunctionJul 3, 2024Break; Break
THE COMPLAINANT ALLEGES, "THE AA03 WITH LOT 0923Y HAD THE TIP AT THE END BREAK DURING USE. NO PATIENT INVOLVEMENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19668393 ↗
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- Bovie AA05Aspen Surgical Products, Inc. · Unit, Cautery, Thermal, Battery-Powered10 reports
- Bovie AA21Aspen Surgical Products, Inc. · Unit, Cautery, Thermal, Battery-Powered4 reports
- Argent 231Mckesson Medical-Surgical Inc. · Unit, Cautery, Thermal, Battery-Powered3 reports
- Accu-Temp® 8442000Beaver-Visitec International, Inc. · Unit, cautery, thermal, battery-powered3 reports
- Argent 244Mckesson Medical-Surgical 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.