Edwards Recalls IntraClude Intra-Aortic Occlusion Device

Edwards LifeSciences has recalled its IntraClude Intra-Aortic Occlusion Device due to balloon rupture risks during use, which could add time to the procedure and compromise patient safety. The balloon bursting “may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke and death,” a recall notice says. The company has logged 22 complaints related to balloon rupture or puncture, with three deaths having been reported.

The device is used in patients undergoing cardiopulmonary bypass, which is a technique in which a machine temporarily takes over the function of the heart and lungs during surgery. When the balloon is inflated, the device blocks and vents (occludes) the aorta so that the heart is accessed without other organs interfering with the procedure, according to the notice.