Megadyne Mega Soft Pediatric Electrode Recall Issued After Burn Injuries Reported

The Johnson & Johnson subsidiary Megadyne has recalled some pediatric electrosurgery electrodes from the market, after at least four children suffered third-degree burn injuries from the pressure reduction pad commonly found in U.S. operating rooms.

The U.S. Food and Drug Administration (FDA) announced the Megadyne Mega Soft Pediatric Patient Return Electrodes recall on June 13, giving it a Class I recall designation, which suggests that continued use of the product may cause serious or life-threatening injuries.

Megadyne MegaSoft pads are reusable by hospitals and medical providers for up to 24 months, providing a substitute for disposable sticky pads. The product is used to conduct monopolar electrosurgical energey from target tissue in a patient back to one or two electrosurgical units or generators, to prevent high current concentrations from building up at the pad site during surgery.

However, the manufacturer now acknowledges that at least four patients have been seriously injured by faulty electrosurgery electrodes, resulting in severe burns.

During 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 and through electrode pads.

The electrodes are soft pads used during electrosurgery for children who weigh between 0.8 and 50 lbs. The pads are placed on the skin of the patient during surgery and conduct an electric current from the patient’s tissues back to the electrosurgical unit to reduce the risk of excessive heating.

However, the electrodes have been linked to the risk of third-degree burn injuries, as well as scarring and the need for additional surgeries.

This isn’t the first time Megadyne has been plagued by faulty electrode products. In July 2023, Megadyne issued a recall for electrosurgery electrodes for adults and pediatric patients, after 63 reports of third-degree burns and other injuries required medical treatment and hospitalization.

Megadyne Electropad Recall

The recall involves Megadyne Mega Soft Pediatric Patient Return Electrodes manufactured by Ethicon, a subsidiary of Johnson & Johnson. The recall affects Mega Soft Pediatric Patient Return Electrodes with product code 0840 and unique device identifier 10614559103395.

Megadyne originally sent out Urgent Medical Device Recall letters to affected customers on May 8. The letters warned consumers and healthcare facilities to stop using the electrode pads and return them to Megadyne. The company also recommended customers:

• Immediately examine their inventory to determine if the product is part of this recall.
• Quarantine any affected products and keep a copy of the notice with the quarantined product.
• Communicate the problem to the operating room and management staff.
• If the recalled product has been forwarded to another facility, contact that facility to arrange for a return.

Healthcare facilities and consumers with questions can call 877-384-4266. Injuries and side effects linked to the Megadyne recalled electrode pads should be reported to the FDA’s MedWatch Adverse Event Reporting program.