Texas Megadyne Electrode Lawyer

Ethicon issued a Class 1 recall for about 21,200 Megadyne electrodes after 99 people suffered burn injuries, including severe 3rd-degree burn injuries.

Need a Texas Megadyne Electrode Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were injured or burned by a Megadyne electrode, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

UPDATE: Megadyne Recalls All MEGA SOFT™ Pediatric Patient Return Electrodes

In May 2024, Megadyne announced a global recall and discontinuation of all MEGA SOFT™ Pediatric Patient Return Electrode Pads due to a risk of severe, life-threatening burn injuries. There were 4 reports of children or infants who were burned by the pads since 2018.

MegaDyne Recalls Mega Soft Electrodes After 99 People Burned

In January 2024, Megadyne recalled Mega Soft Universal Patient Return Electrodes after 99 reports of burn injuries.

Megadyne issued the recall to update the instructions and labeling to warn that the Mega Soft Universal electrode pads should not be used in patients under 12 years old.

According to the recall:

“Megadyne has received reports of patient burn injuries, including third-degree burns requiring intervention. Burn injuries may lead to extended hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.”

MEGA Electrode Pads Recalled After Severe Burn Injuries Reported

In July 2023, Ethicon recalled about 21,200 Megadyne MEGA electrode pads after at least 63 patients were burned, including adults and children who suffered severe 3rd-degree burns.

Use of these recalled electrode pads “may cause serious injury or death,” according to the FDA:

“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.”

Ethicon Warns Doctors About Burn Hazard

In June 2023, Johnson & Johnson’s medical device subsidiary Ethicon Inc. sent an Urgent Medical Device Correction Letter to warn about a risk of severe burns from Megadyne MEGA Patient Return Electrodes.

FDA Issues Class 1 Recall

On July 21, 2023, the FDA announced a Class 1 recall involving about 21,200 Megadyne MEGA Patient Return Electrodes. This Class 1 recall is “the most serious type of recall. Use of these devices may cause serious injuries or death,” according to the FDA warning.

What MEGA Electrodes Were Recalled?

The Class 1 recall involves the following MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes:

• MEGADYNE MEGA 2000 Patient Return Electrode 0800
• MEGADYNE MEGA SOFT Reusable Patient Return Electrode 0830
• MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode 0835
• MEGADYNE MEGA SOFT Pediatric Patient Return Electrode 0840
• MEGADYNE MEGA SOFT Universal Patient Return Electrode 0845
• MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode 0846
• MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode 0847
• MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode 0848

The recalled Megadyne electrode pads were distributed in the U.S. from March 11, 2021 to May 9, 2023.

What Type of Electrosurgical Pads Were Recalled?

The recall involves electrode pads, which stick to the skin of a patient and conduct the electrical current from the patient’s body back to the electrosurgical unit. They are used during electrosurgery, which uses an electrical current to heat or cut tissue, or stop bleeding.

What Causes Pad-Site Burns?

Megadyne said it is continuing to evaluate the root cause of patient burns.

In a Guide to Patient Return Electrode Injuries, Ethicon warned about several potential causes for pad-site burns:

“Long duty cycles and high generator power settings may contribute to pad-site burns. Placement of adhesive return electrodes over bony prominences, scar tissue, metal prostheses, hair, tattoo, potential pressure points or fluid may lead to pad-site injury.”

Need a Megadyne Electrode Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.