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  • Regulatory NewsRegulatory News

    Edwards Lifesciences Recalls Devices After 3 Deaths Reported

    The US Food and Drug Administration (FDA) recently announced a Class I recall of more than 700 Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Devices after receiving 22 complaints related to balloon rupture or puncture, including three deaths. The device is used in patients undergoing cardiopulmonary bypass — a technique described by FDA as when “a machine temporarily takes over the function of the heart and lungs during surgery. When the IntraClude balloon is ...