The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names and Codes:
- 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
- Devices Recalled in the U.S.: 21,200
- Dates Distributed: March 11, 2021 – May 9, 2023
- Date Initiated by Firm: June 1, 2023
Device Use
MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes are soft pads used during electrosurgery. In electrosurgery, an electric current is used to heat or cut tissue or to stop bleeding. The electric current is generated by an electrosurgical generator and delivered to the tissue with a small pen-like attachment. A return electrode pad contacts the skin of the laying patient during use and conducts the electric current from the patient’s tissue back to the electrosurgical unit, or generator, to reduce the risk of excessive heating.
Reason for Recall
Megadyne is recalling MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving reports of patients receiving burn injuries from use in both pediatric and adult patients. 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. Megadyne is continuing to evaluate the root cause for patient burns.
Use of affected products may cause serious injury or death.
Megadyne reports 63 injuries and no deaths related to this issue. If additional actions are necessary to further help ensure the safe use of these devices, Megadyne will notify customers.
