FDA Letter to Health Care Providers Emphasizes Safe Use of Megadyne Patient Return Electrodes
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The Food and Drug Administration has published a letter to health care providers to raise awareness about how to use certain Megadyne products safely.
The focus is primarily on the company’s MEGA 2000 and MEGA SOFT Patient Return Electrodes, which are used during electrosurgery. There have been reports of burns resulting from the use of these products dating back to 2023, including some burns serious enough to be categorized as third-degree.
In its letter, the FDA reemphasized instructions from Megadyne that providers should not use the MEGA 2000 and several types of MEGA SOFT electrodes on patients under 12, while the recently recalled MEDGA SOFT Pediatric Patient Return Electrodes should not be used at all.
Lawyers are currently accepting cases from people who suffered burns from Megadyne products that were used during their surgeries.
Megadyne Electrode Concerns First Arose in 2023
Megadyne’s electrode pads have been the subject of multiple recalls over the last year.
The company recalled certain products in June 2023 due to reports of burn injuries during surgeries that utilized the pads.
According to the FDA, the pads make contact with the patient’s skin during electrosurgery to conduct the electric current used to heat or cut the tissue in their body.
Megadyne initially recalled its MEGA 2000 product along with several MEGA SOFT products. The FDA identified the move as a Class I recall, the most serious kind.
By December of that year, Megadyne had issued an urgent medical device correction notice, stating that doctors should not use the MEGA SOFT Universal, Universal Plus and Universal Plus Dual Pads on patients younger than 12.
The company later issued a recall of its MEGA SOFT Pediatric Patient Return Electrode in May of this year, while also opting to discontinue the product.
Reports of Burns and Increased Risk for Children Led to Megadyne Recalls
According to the FDA, there have been 99 reported injuries so far connected to Megadyne products. Evidence suggests that pediatric patients could be at higher risk.
Some burns have been serious, including third-degree burns that required intervention. In its recently released letter, the FDA emphasized the impacts that burn injuries of this nature can have, including prolonged hospital stays, additional surgeries and scarring.
Pediatric patients have also become a focal point of the concerns.
When Megadyne recalled their MEGA SOFT Pediatric Patient Return Electrode, an investigation showed that the combination of factors that can result in burns were more likely when the patients were infants or young children.
Megadyne had designed the pediatric pads for patients who weighed between 0.8 and 50 pounds, meaning that they were likely to be used on that group.
While there were four injury reports in connection with that specific product, there have been no reports of deaths connected to any of the affected Megadyne electrodes.
Editor Lindsay Donaldson contributed to this article.