MEGADYNE™ Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT™ Pediatric Patient Return Electrode

Summary

Company Announcement Date:: May 10, 2024
FDA Publish Date:: May 10, 2024
Product Type:: Medical Devices
Reason for Announcement:: Recall Reason Description

Reports of patient burn injuries
Company Name:: Megadyne Medical Products Inc.
Brand Name:: Brand Name(s)

Ethicon Megadyne
Product Description:: Product Description

Mega Soft Pediatric Patient Return Electrode

Company Announcement

Cincinnati, OH – May 10, 2024 – MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries.

The combination of these conditions may be more likely when the pad is used with infants and small children. Because the pediatric pad is designed for patients between 0.8 to 50 pounds, which would be predominantly patients under the age of 12, the decision was made to discontinue and recall the 0840 pediatric pad product.

Between 2018 and today, there have been 4 reported injuries and no reports of death associated with this product. The Company has decided to discontinue and voluntarily recall the MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode. U.S. (Food and Drug Administration) FDA has been notified of this action.

Customers who have MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes should stop using them and return them. The recall includes the following product code, which can be identified by name Pediatric Return Electrode Pad shown on the pad.

Product Name	Product Code	UDI-DI
MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode	0840	10614559103395

Megadyne is notifying global customers and distributors by mail and is arranging for return of impacted product. Product was distributed in the United States and international markets.

Customer with questions may contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266) Monday through Friday, 8:00 AM to 5:00 PM ET.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: here
FDA form 3500 available here
Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178