BOVIE H121Recalls & reported problems
Aspen Surgical Products, Inc. · REPLACEABLE ELONGATED TIP · Class 2
All models of Bovie (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607151071219), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2022Break
THE CUSTOMER ALLEGED THAT THE BOVIE CAUTERY REPLACEMENT TIPS ARE BREAKING OFF. ONE TIP BROKE OFF WHILE IN USE AND BURNED A PATIENT DURING A VASECTOMY. THE BURN WAS NOT SERIOUS AND DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION.
Patient problems: Superficial (First Degree) Burn
MAUDE report 13538711 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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