This action is a correction, not a product removal.
Megadyne recalled its Mega Soft Universal, Universal Dual, Universal Plus and Universal Plus Dual patient return electrodes. It initiated the recall on Dec. 8, with the action affecting 9,428 devices distributed between Oct. 1, 2021, and Dec. 4, 2023.
The company initiated this recall to update the instructions for use and product labeling. It seeks to restrict device use to patients 12 years and older. Megadyne received reports of patient burn injuries, including third-degree burns requiring intervention. Burn injuries could lead to extended hospital stays, scarring and additional surgeries.
Severe burns could lead to potentially long-lasting impacts on patients, especially those under the age of 12. Megadyne reports 99 injuries with zero instances of death related to the issue.
Last year, the company recalled a number of Megadyne Mega Soft electrodes and the Mega 2000 electrodes due to a similar issue.
The electrodes are used in surgeries involving the use of electrosurgical instruments. Their design aims to ensure the safety of the patient by providing a safe return path for the electrical current used in these procedures. The electrodes are supposed to minimize the risk of electrical burns by ensuring the current flows safely through the patient’s body.
The electrode’s purpose is to minimize the risk of electrical burns by ensuring the current flows safely through the patient’s body and back to the electrosurgical unit, preventing any concentration of electrical energy in one area of the body. It’s an important safety measure in procedures involving electrosurgery to protect the patient from electrical injury.
Megadyne instructed all affected customers to share the information of the change in intended use with all users.
Megadyne Medical statement on the recall
A Megadyne spokesperson issued the following statement regarding the recall:
“As part of our continued discussion with the FDA on the safe and effective use of Mega Soft pads, we worked with the agency to issue a medical device correction and limit MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes for use in patients age 12 years or older. MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should no longer be used for patients that are children under the age of 12 years old. MEGA SOFT Pediatric Reusable Patient Return Electrodes (indicated for patients from 0.8 lbs. and up to 50 lbs.) are not subject to this medical device correction and remain available for use.
The safe and effective use of our products is our top priority, and we have notified customers and regulatory authorities in impacted countries. This notification was not a product removal and Mega Soft pads may continue to be used as indicated.
Mega Soft pads have been used for more than 20 years in more than 100 million surgical procedures.”