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  5. Dear Veterinarian Letter advising veterinarians of burn risk associated with the use of Megadyne grounding pads in veterinary patients
  1. Product Safety Information

Dear Veterinarian Letter advising veterinarians of burn risk associated with the use of Megadyne grounding pads in veterinary patients

Dear Veterinarian:

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) would like to make you aware of a recall for human medical devices associated with burn injuries in children. CVM has received reports of burn injuries in animals associated with veterinary use of these human medical devices.

Devices affected by the recall include Megadyne MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes. MEGADYNE MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Reusable Patient Return Electrodes are soft pads used during electrosurgery. In electrosurgery, an electric current is used to heat or cut tissue or to stop bleeding. The electric current is generated by an electrosurgical generator and delivered to the tissue with a small pen-like attachment. A return electrode pad contacts the skin of the patient during use and conducts the electric current from the patient's tissue back to the electrosurgical unit, or generator, to reduce the risk of excessive heating.

Megadyne is correcting the MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes after receiving reports of patient burn injuries, especially in children under 12 years of age, after procedures where the MEGA 2000 and MEGA SOFT Patient Return Electrodes were used. The recall involves updating instructions for using these devices and does not involve removing them from where they are used or sold. Megadyne is instructing users to not use MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes during procedures with patients under 12 years old and to follow proper cleaning, placement, and setup steps for MEGA SOFT and MEGA 2000 pads to help prevent patient burns.

The animal adverse event reports received by the FDA included dogs of varying weights and ages. Human medical devices are often used for animal patients in veterinary practice. FDA has regulatory oversight over devices intended for animal use and can take appropriate regulatory action if an animal device is misbranded or adulterated. However, FDA does not currently have premarket authority over devices intended solely for animals.

The FDA encourages veterinarians and animal owners to report adverse experiences and product defects associated with animal devices. More information about how to report information about animal drugs and devices can be found at our website: How to Report Animal Drug and Device Side Effects and Product Problems.

For more information, please contact AskCVM@fda.hhs.gov.

Sincerely,

FDA’s Center for Veterinary Medicine

 

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