Class I Recall
On July 11, 2023, the FDA labeled a Class I recall for Megadyne’s MEGA 2000 and MEGA electrodes products, manufactured by Johnson & Johnson’s Ethicon, due to the risk of serious burns to patients. These devices are claimed to be used in more than 100 million procedures across the world. The FDA identifies a Class I recall as the most serious type of recall, in which these devices may cause serious injuries or death.
The recall affects a considerable sum of 21,200 devices that were distributed in the U.S. from March 11, 2012 to May 9, 2023. At this time Megadyne reported 63 injuries and no deaths related to the issue, but they are continuing to evaluate the root cause for patient burns. Make sure to speak with a Chicago defective medical device attorney for legal guidance if impacted.
What is a Reusable Patient Return Electrodes and How is it Used?
MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes are soft pads used during electrosurgery, where an electric current is used to heat or cut tissue or to stop bleeding.
Specifically, 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 the Recall
According to the statement issued by Megadyne on June 1st, 2023, the electrodes products were recalled after receiving reports of pediatric and adult patients who received burn injuries from the devices.
These burns may be as serious as third-degree burns requiring medical intervention. They also could lead to a longer hospital stay, scarring, and potentially more surgeries for patients.
At this time, Megadyne reported 63 injuries and no deaths related to the issue, but they are continuing to evaluate the root cause for patient burns. The recall affects a considerable sum of 21,200 devices that were distributed in the U.S. from March 11, 2012, to May 9, 2023. The product names and codes recalled are listed below:
- 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
What Guidelines Have Been Given?
On June 1, 2023, Megadyne sent an Urgent Medical Device Correction letter to customers that included the following recommended actions:
- Share the notification with all users involved in MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes cleaning, operating room and patient setup, and device operation during procedures.
- Confirm that personnel using the MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes are following the instructions for use as shown in the letter and available at: https://www.eifu.com
- Post the “Cleaning and Care Visual Aid and Placement and Setup Visual Aid,” both included as attachments to the letter, near the operating room to remind staff about instructions for cleaning and setup.
The letter also noted that health care providers who have used MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes during patient procedures should follow patients post-operatively in the same way with no additional action required related to the correction.
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How Can Meyers & Flowers Help?
The Meyers & Flowers team of Chicago personal injury attorneys is dedicated to protecting the rights of those injured by defective and dangerous medical devices. If you or a family member have been injured by the ARROW Endurance Extended Dwell Peripheral Catheter System, we encourage you to contact us to explore your legal options.
