Bovie E15644Recalls & reported problems
Aspen Surgical Products, Inc. · 4.0”, 5mm Ball Electrode · 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 10607151009868), received between Nov 20, 2023 and Nov 20, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Melted” (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.
Reports received per month
Most reported problems
Device problems
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2023Melted; Melted
THE CUSTOMER ALLEGED THAT THE BALL TIP ELECTRODE CHARRED AND THE PLASTIC MELTED DURING A LAPAROSCOPIC PROCEDURE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18176590 ↗
Other Electrocautery, Gynecologic (And Accessories) devices
- Enseal NSLX137CEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)3 deaths344 reports
- ENSEAL X1 NSLX120LEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)2 deaths172 reports
- Fischer Cone Biopsy Excisor 900-157Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)1 recall0 reports
- LEEP PRECISION™ Generator LP-20-120Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)45 reports
- Harmonic NSLX137SEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)1 death19 reports
- LEEP PRECISION™ Integrated System LP-10-120Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)12 reports
- Fischer Cone Biopsy Excisor 900-151Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)10 reports
- AESCULAP PM438RAesculap AG · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)7 reports
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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