FDA delivers Class I label to J&J’s recall of electrosurgery pads, following patient burns

One of Johnson & Johnson’s medical device subsidiaries is recalling thousands of electrode pads used during surgery, following reports of burns among adult and pediatric patients. 

This week, the FDA granted the recall its Class I designation, the agency’s most serious type, due to the potential risks of injuries or death. 

The recall by J&J’s Ethicon division was first launched in early June and spans more than 21,000 devices distributed to hospitals and surgery centers over a two-year period. They include Megadyne’s Mega Soft and Mega 2000 electrode pads for use during electrosurgery—where the heat from a focused electric current is delivered from a handheld, pen-like tool and used to cut through tissue and help cauterize bleeding.

The Megadyne conductive pads at the center of the recall are placed elsewhere on the skin of the patient, to help complete the circuit and return the flow of current back to the electrical generator.

According to a public notice from the FDA, the company has reported 63 injuries and no deaths associated with the recall. “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,” the agency said. 

Ethicon acquired the devicemaker Megadyne in January 2017 for an undisclosed amount, estimating at the time that electrosurgical devices are used in nearly 80% of all surgeries. In addition to return pads, Megadyne’s portfolio included electrodes, generators and smoke removal systems. 

The FDA said the company is continuing to evaluate the root cause of the patient burns. In a statement to Fierce Medtech, Megadyne said a “thorough investigation was conducted, and no design or manufacturing defects have been identified to date.”

In a letter to healthcare providers sent June 1, the company recommended that clinicians inform operating room staff of the proper instructions for cleaning, setting up and placing the reusable pads in order to reduce the risk of a burn.

In its statement this week, the company said that the pads remain available and, when used in accordance with the products’ labeling, can be a safe alternative to disposable return electrodes.

Megadyne added that the devices have been used in more than 100 million surgical procedures, with more than 27,000 reusable pads in circulation globally during the past five years.

According to the FDA, if any additional actions such as device returns become necessary, Megadyne will notify its customers.