Recalled products include a number of Megadyne Mega Soft electrodes and the Mega 2000 patient return electrode. Ethicon paid an undisclosed amount to acquire Megadyne Medical Products in 2017 after several years of collaboration.
According to an FDA notice, the recall affects 21,200 devices in the U.S. The firm distributed those devices between March 11, 2021, and May 9, 2023, before initiating the recall on June 1, 2023.
The Mega 2000 and Mega Soft reusable patient return electrodes are soft pads used during electrosurgery. During these procedures, an electric current heats or cuts tissue or stops bleeding. An electrosurgical generator creates the electric current and a small, pen-like attachment delivers the current to the tissue.
A return electrode pad contacts the skin during use and conducts the current from the patient’s tissue back to the generator. This reduces the risk of excessive heating.
Why Ethicon/Megadyne recalled the devices
Ethicon/Megadyne recalled the devices after receiving reports of burn injuries in pediatric and adult patients. The burns may register as serious as third-degree burns requiring medical intervention. They could also lead to a longer hospital stay, scarring and more surgeries, the FDA said.
Ethicon/Megadyne continue to evaluate the root cause for patient burns. The FDA says the use of the products may cause serious injury or death.
To date, Ethicon/Megadyne report 63 injuries and no deaths related to the issue.
On June 1, the firm sent an urgent medical device correction letter to alert users of the potential issue. The letter recommended that users confirm that they follow the instructions for use. They should also post the “Cleaning and Care Visual Aid and Placement and Setup Visual Aid” included as attachments to the letter near the operating room to remind staff about instructions for cleaning and setup.
The letter noted that providers using the electrodes should follow patients post-operatively in the same way. They require no additional action required related to the device correction.
Megadyne statement
A Johnson & Johnson MedTech spokesperson shared the following statement on the recall with MassDevice:
“At Megadyne, our first priority is to our customers and their patients, and that includes the safe and effective use of our products.
“In collaboration with the United States Food and Drug Administration, we issued a notification to healthcare professionals who have purchased Mega Soft pads. The notification emphasized the importance of following the Instructions for Use (IFU), including proper cleaning and setup to help reduce the potential for a burn.
” This notification was not a product removal and Mega Soft pads may continue to be used. Mega Soft pads remain available and, when used in accordance with the products’ labeling, are a safe alternative to disposable return electrodes.
“Mega Soft pads have been used in more than 100 million surgical procedures. In the past five years, more than 27,000 reusable Mega Soft pads have been in use globally.”
