Bovie ESRSCRecalls & reported problems
Aspen Surgical Products, Inc. · DISPOSABLE SOLID ADULT RETURN ELECTRODE WITH CABLE · Class 2
All models of Bovie (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00607151001674), received between May 4, 2022 and May 4, 2022 — classified as 4 malfunctions.
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
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Superficial (First Degree) Burn4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2022Adverse Event Without Identified Device or Use Problem
THE CUSTOMER ALLEGED THAT WHILE USING THE ESRS THE PATIENT RECEIVED MILD BURNS AT THE APPLICATION SITE OF THE RETURN ELECTRODE PADS.
Patient problems: Superficial (First Degree) Burn
MAUDE report 14280079 ↗MalfunctionMay 4, 2022Adverse Event Without Identified Device or Use Problem
THE CUSTOMER ALLEGED THAT WHILE USING THE ESRS THE PATIENT RECEIVED MILD BURNS AT THE APPLICATION SITE OF THE RETURN ELECTRODE PADS. THERE ARE NO SPECIFIC DETAILS AVAILBLE AS IT WAS REPORT A FEW DAYS POST SURGERY.
Patient problems: Superficial (First Degree) Burn
MAUDE report 14280078 ↗MalfunctionMay 4, 2022Adverse Event Without Identified Device or Use Problem
THE CUSTOMER ALLEGED THAT WHILE USING THE ESRS THE PATIENT RECEIVED MILD BURNS AT THE APPLICATION SITE OF THE RETURN ELECTRODE PADS. THERE ARE NO SPECIFIC DETAILS AVAILABLE AS IT WAS REPORT A FEW DAYS POST SURGERY.
Patient problems: Superficial (First Degree) Burn
MAUDE report 14280069 ↗MalfunctionMay 4, 2022Adverse Event Without Identified Device or Use Problem
THE CUSTOMER ALLEGED THAT WHILE USING THE ESRS THE PATIENT RECEIVED MILD BURNS AT THE APPLICATION SITE OF THE RETURN ELECTRODE PADS. THERE ARE NO SPECIFIC DETAILS AVAILBLE AS IT WAS REPORT A FEW DAYS POST SURGERY.
Patient problems: Superficial (First Degree) Burn
MAUDE report 14280035 ↗
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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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