Megadyne Electrode Risks Highlighted in FDA Warning Letter Sent to Doctors

FDA is urging doctors not to use the Megadyne electrodes on patients younger than 12 years old, due to a risk of severe burn injuries.

Federal safety officials are warning doctors about the risk of severe burns linked to certain Megadyne pediatric electrodes, following a series of recent recalls and adverse event reports filed by medical providers nationwide, with some of the most significant injuries impacting patients under 12 years of age.

The U.S. Food and Drug Administration (FDA) issued a Megadyne Electrode warning letter on July 31, urging healthcare providers not to use the recalled models on patients, particularly children.

According to the agency, Megadyne electrodes have caused burn injuries for both adults and children, resulting in the need for medical intervention, prolonged hospital stays, scarring and the need for additional surgery. Some of the incidents involved third degree burns that also damage the underlying bones, muscles and tendons, resulting in permanent nerve damage.

Previous Megadyne Electrode Recalls

Megadyne Mega 2000 and Mega Soft Patient Return Electrodes are medical devices used in electrosurgery to safely return the electrical current from the patient back to the electrosurgical generator. These electrodes are designed to minimize the risk of burns by providing a large surface area for the return of the electrical current, ensuring effective grounding and reducing heat build-up.

Since 2023, the manufacturer has issued a number of recalls for the Megadyne Electrodes. One of the most recent was announced on June 13, 2024, for Megadyne Mega Soft Pediatric Patient Return Electrodes after at least four children suffered third-degree burn injuries from the pressure reduction pad.

In July 2023, Megadyne also 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.

The FDA is recommending healthcare providers avoid the use Mega Soft Pediatric Patient Return Electrodes for any age group, urging doctors to review the information for Megadyne’s May 2024 recall of these electrodes, as well as all other recent Megadyne recalls.

Doctors should only use Mega 2000 and Mega Soft Patient Return Electrodes on patients 12 years and older, despite their current labeling for smaller weights. These devices should not be used on neonates, infants, or children under 12 years old, the FDA warns.

Health care providers should also review the recalls from June 2023, December 2023, and June 2024, which corrected the intended use population to patients 12 years and older and provided updated cleaning, placement, and setup instructions. They should follow the Instructions for Use (IFU) for proper cleaning, placement, and setup of Mega 2000 and Mega Soft Patient Return Electrodes and monitor patients post-operatively as usual.

Health care providers with questions about the recalls of Mega Soft Pediatric, Mega 2000, or Mega Soft Patient Return Electrodes, should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266), Monday to Friday, 8:00 AM to 5:00 PM ET.