Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to Patients | FDA

The devices listed below are included in the FDA’s “Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers” issued on July 31, 2024.

This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Figure 1: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode

On May 8, 2024, Megadyne sent all affected customers an Urgent Medical Device Recall (Removal) letter recommending the following actions.

Megadyne is recalling MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes after receiving reports of patient burn injuries in procedures where the MEGA SOFT Pediatric Patient Return Electrodes were used.

The use of affected product may cause serious adverse health consequences for pediatric patients, including third-degree burns, scarring, and additional surgeries.

There have been four reported injuries. There have been no reports of death.

MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes are soft pads used during electrosurgery for children who weigh between 0.8 and 50 lbs. 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.

Customers in the U.S. with questions about this recall should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

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.

07/31/2024