On July 31, 2024, Health Canada announced the recall of Megadyne Mega 2000™ and Mega Soft™ Patient Return Electrodes after reports that these devices caused patients and healthcare professionals to experience severe burn injuries.
Mega 2000 and Mega Soft Patient Return Electrodes are designed for monopolar electrosurgery.
The products facilitate the safe return of electrical energy from the patient back to the electrosurgical unit.
The Mega Soft Universal (Pediatric) Patient Return Electrode, identified by product code 0840, was designed for patients who weighed under 22.7 kilograms. Megadyne has issued a full recall of this product, advising that it should not be used to treat persons of any age.
The Mega 2000 and Mega Soft Patient Return Electrodes, identified by product codes 0800, 0830, 0835, 0845, 0846, 0847, and 0848, are now restricted for use on patients 12 or older. This product has been deemed unsafe for those under 12 years of age due to the potential risk of long-term effects of burn injuries on patients of these ages.
If you were affected by this recall, reach out to Slater Vecchio LLP for a free consultation: https://www.slatervecchio.com/contact/
