This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
Figure 1: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode
- Product Name: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode
- Product Code: 0840
- Unique Device Identifier (UDI): 10614559103395
What to Do
- Health care providers and facilities who use MEGA SOFT Pediatric Patient Return Electrodes during patient procedures should stop using them and return them to Megadyne.
On May 8, 2024, Megadyne sent all affected customers an Urgent Medical Device Recall (Removal) letter recommending the following actions.
- Examine inventory immediately to determine if product subject to this recall is on hand.
- Quarantine affected products and keep a copy of the notice with the quarantined product.
- Communicate the issue to relevant operating room or materials management staff or anyone else in the facility who needs to be informed.
- If product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Consider including a copy of the recall letter when communicating.
- Complete the Business Reply Form (BRF) attached to the letter to confirm receipt of the notice and fax or email to Sedgwick at 800-978-9457or ethicon4284@sedgwick.com within three business days. Please return the BRF even if you do not have product subject to this recall.
- Customers are required to immediately return all MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes subject to this recall.
- To receive credit reimbursement, customers must return product as soon as possible and no later than August 31, 2024. Any non-affected product and any product returned after the date specified will not receive credit reimbursement.
- To return product, make a copy of the BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Megadyne will pay for the shipping charges only if the authorized label is used. Account number and mailing address have been pre-populated on the BRF.
- For assistance with returning product or to obtain extra shipping labels, please contact Sedgwick at 888-912-7090 and reference Event # 4284.
- Keep the notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick.
Reason for Recall
Megadyne is recalling MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes after receiving reports of patient burn injuries in procedures where the MEGA SOFT Pediatric Patient Return Electrodes were used.
The use of affected product may cause serious adverse health consequences for pediatric patients, including third-degree burns, scarring, and additional surgeries.
There have been four reported injuries. There have been no reports of death.
Device Use
MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes are soft pads used during electrosurgery for children who weigh between 0.8 and 50 lbs. 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.
Contact Information
Customers in the U.S. with questions about this recall should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).
Additional FDA Resources
Additional Company Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
