Megadyne Burn Risks From Recalled Electrode Pads May Also Extend to Pets: FDA Warns
Human brand of electrode pads have faced numerous recalls since 2023 and can also be used on animals.
Federal regulators are warning veterinarians that using Megadyne electrode pads, designed for human use, have been linked to patient burns in veterinary settings.
Megadyne MegaSoft pads are reusable electrode pads designed to prevent high concentrations of electrical current at the electrosurgical pad site during surgery. The devices conduct monopolar energy from the patient’s target tissue back to the generator and can be used by hospitals and medical providers for up to 24 months, offering an alternative to disposable sticky pads.
However, multiple Megadyne Mega Soft Electrode Pad recalls have been issued by the U.S. Food and Drug Administration (FDA) since 2023. In particular, an FDA warning letter was issued to doctors in August 2024 for children 12 and under, due to the possibility of severe burns at the pad site. A Megadyne lawsuit was then filed in December 2024 alleging that a 5-year-old child was severely burned by the recalled electrode pads during a tonsillectomy.
The FDAs Center for Veterinary Medicine (CVM) has now issued a warning letter to veterinarians, indicating the agency has received numerous reports of burns on animals as well as humans as a result of the use of the recalled Megadyne electrode pads.
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Learn MoreIn September 2024, the manufacturer issued a correction for MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrode Pads, which prompted an FDA warning. The correction included updated usage instructions but allowed the pads to remain in use.
The Megadyne warning specifically advised against using the pads on patients aged 12 years or younger, and emphasized the importance of proper cleaning, placement and setup to minimize the risk of burn injuries.
Following a growing number of reports linking the devices to burn injuries in veterinary settings, the FDA broadened the scope of the warning to include a product advisory directed at veterinarians.
In addition to regulating medical devices for human use, the FDA also oversees devices intended for animals and has the authority to take regulatory action when safety concerns are identified.
Veterinarians and animal owners who experience adverse events or product defects involving devices used on animals can contact AskCVM@fda.hhs.gov. Individuals can also find more information on how to report their experiences to the FDA at How to Report Animal Drug and Device Side Effects and Product Problems.
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