Bovie ESRSRecalls & reported problems
Aspen Surgical Products, Inc. · DISPOSABLE SOLID ADULT RETURN ELECTRODE · Class 2
All models of Bovie (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607151001681), received between Jun 23, 2022 and Aug 12, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Circuit Failure1
- Energy Output Problem1
Patient problems
- Burn(s)2
- Superficial (First Degree) Burn1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Circuit Failure
Patient problems: Burn(s)
MAUDE report 50226804 ↗MalfunctionJun 23, 2022Adverse Event Without Identified Device or Use Problem
THE PATIENT RECEIVED BURNS FROM THE ESRS GROUNDING PAD WHILE BEING USED WITH A STRYKER MULTIGEN 2RF GENERATOR.
Patient problems: Burn(s)
MAUDE report 14793986 ↗MalfunctionJun 23, 2022Energy Output Problem
THE PATIENT RECEIVED BURNS FROM THE ESRS GROUNDING PAD WHILE BEING USED WITH A STRYKER MULTIGEN 2RF GENERATOR. THE BURNS ONLY OCCURRED TO THE PLACE WHERE THE PAD WAS ADHERED.
Patient problems: Superficial (First Degree) Burn
MAUDE report 14793886 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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