Magadyne Mega Soft Pediatric Patient Return Electrode Recalled, Globally Discontinued

The company said that if a specific combination of factors comes together, there is a risk of thermal injury.

Katie Hobbins, Managing Editor

May 14, 2024

1 Min Read
FDA recall
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Magadyne Medical Products recently announced the recall of all Megadyne Mega Soft Pediatric Patient Return Electrodes after reports of patient burn injuries in procedures in which the product was used. After the reports, a root cause investigation included testing which showed a combination of factors that, when together, may result in thermal injuries.

The electrode pad is designed for patients between 0.8 and 50 pounds — predominantly patients under the age of 12. As the combination of conditions that may result in injury are potentially more likely when the pad is used with infants and small children, the company decided to discontinue and recall the product.

Magadyne reported it has received four reports of injury and no reports of death associated with the recall since 2018. Customers who are in possession of the Mega Soft electrode pad are urged to stop use and return the product — which can be identified by product code 0840.

Last year, the company recalled some Mega Soft electrodes and the Mega 2000 electrodes. Then in 2024, another of its Mega Soft electrodes was deemed Class I by FDA. The recall, much like the most recent iteration, came after reports of burn injuries, including third-degree burns which required additional intervention.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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