Edwards LifeSciences is recalling its IntraClude intra-aortic occlusion device following a handful of complaints and three reported deaths, the FDA announced.
So far, the devicemaker has received 22 complaints related to balloon rupture or puncture and has reported three deaths resulting from use of the device.
The occlusion device is used in patients undergoing cardiopulmonary bypass, a technique in which a medical device temporarily functions as a patient’s heart and lungs during surgery. Bursting of the device’s balloon could cause serious adverse health consequences from the prolonged time a patient must be on cardiopulmonary bypass, the FDA said.
