Recently the US Food and Drug Administration labeled a Class I recall for Megadyne’s MEGA 2000 and MEGA electrodes products, manufactured by Johnson & Johnson’s Ethicon, due to the risk of serious burns to patients. These devices are claimed to be used in more than 100 million procedures across the world. The FDA identifies a Class I recall as the most serious type of recall, in which these devices may cause serious injuries or death.
WHAT IS A REUSABLE PATIENT RETURN ELECTRODES AND HOW IS IT USED?
MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes are soft pads used during electrosurgery, where an electric current is used to heat or cut tissue or to stop bleeding.
Specifically, 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 laying 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.
REASON FOR THE RECALL
According to the statement issued by Megadyne on June 1st, 2023, the electrodes products were recalled after receiving reports of pediatric and adult patients who received burn injuries from the devices.
These burns may be as serious as third-degree burns requiring medical intervention. They also could lead to a longer hospital stay, scarring, and potentially more surgeries for patients.
At this time Megadyne reported 63 injuries and no deaths related to the issue, but they are continuing to evaluate the root cause for patient burns. The recall affects a considerable sum of 21,200 devices that were distributed in the U.S. from March 11, 2012 to May 9, 2023.
To learn more about the recall for Megadyne electrode products, click here.
HOW CAN MEYERS & FLOWERS HELP
The Meyers & Flowers team is dedicated to protecting the rights of those injured by defective and dangerous medical devices. If you or a family member have been injured by Megadyne’s MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, we encourage you to contact us to explore your legal options. Contact us at 630-576-9696 for your free, no obligation case evaluation or find more information here.