The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Return Electrode
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
On July 21, 2023, the FDA updated this communication to correct the recommended actions for customers. This recall is a voluntary correction, not a product removal. Customers should follow the recommended actions described below.
MEGA 2000 (Figure 1) and MEGA SOFT (Figure 2) 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 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.
Megadyne is recalling MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving reports of patients receiving burn injuries from use in both pediatric and adult patients. These burns may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries for pediatric and adult patients. Megadyne is continuing to evaluate the root cause for patient burns.
Use of affected products may cause serious injury or death.
Megadyne reports 63 injuries and no deaths related to this issue. If additional actions are necessary to further help ensure the safe use of these devices, Megadyne will notify customers.
On June 1, 2023, Megadyne sent an Urgent Medical Device Correction letter to customers that included the following recommended actions:
The letter also noted that health care providers who have used MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes during patient procedures should follow patients post-operatively in the same way with no additional action required related to the correction.
Customers with questions about this recall should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
Ecg Monitoring Electrodes Sign up to receive email updates on medical device recalls, safety communications, and other safety information.