The Cobra Fusion device is designed to deliver both bipolar and monopolar energy to the ablation site. The device also uses suction to gently pulls tissue out of the path of circulating blood to eliminate the heat sink effect during both modalities, according to AtriCure’s website.
In a Sept. 21 letter to physicians, AtriCure said the magnet and/or magnet cap at the distal end of the device could dislodge and remain behind when the device is removed from the patient.
“ln this event, the magnet and/or magnet cap would need to be removed prior to completion of the surgical procedure. Failure to remove the magnet and/or magnet cap from the body cavity prior to closure could potentially cause permanent impairment of body function or permanent darnage to a body structure,” AtriCure wrote.
West Chester, Ohio-based AtriCure said it had received no reports of serious injuries or deaths as of Sept. 21. The notice affects all Cobra devices made before February 2016, the company wrote.
AtriCure acquired the Cobra Fusion platform when it paid $34 million for San Ramon, Calif.-based Estech back in January 2014 in an all-stock transaction.