On June 1, 2023, the U.S. Food & Drug Administration (FDA) recalled Megadyne’s reusable patient return electrode devices due to serious risks of burn injuries or death.
MEGA 2000 and MEGA SOFT reusable patient return electrodes are soft pads used during electrosurgery. In electrosurgery, an electric current is used to heat tissue, cut tissue, or stop bleeding. The return electrode pad is placed on the patient’s skin, conducting an electric current from the tissue back to the electrosurgical unit.
According to the FDA, the MEGA Soft reusable patient return electrode is a Class I recall, the most serious type of recall. This recall type can cause serious injuries or even death.
Burns from the recalled electrode devices may be as serious as third-degree burns, requiring medical attention, longer hospital stays, scarring, and potential additional surgeries.
According to Megadyne, 63 injuries have been reported due to the recalled electrode devices.
The patient return electrode devices were distributed between Mar. 11, 2021, and May 9, 2023. Over 21,000 electrode devices were recalled in the U.S.
What patient electrode models are included in the recall?
The patient electrode return medical device recall includes the following product names and codes:
- MEGADYNE MEGA 2000 Patient Return Electrode 0800
- MEGADYNE MEGA SOFT Reusable Patient Return Electrode 0830
- MEGADYNE MEGA SOFT 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
Questions About a Patient Electrode Burn Injury Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
If you or a loved one has been burned by a recalled patient electrode device, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting new patient electrode recall lawsuits across the country, and you may be entitled to financial compensation.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386.
We would be honored to speak with you and respond promptly to every inquiry we receive.