American College of Cardiology Foundation

07/19/2019 | Press release | Archived content

FDA Update: Edwards LifeSciences Recalls IntraClude Intra-Aortic Occlusion Device

Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device, used in patients undergoing cardiopulmonary bypass, due to a risk of balloon rupture during use.

According to the Food and Drug Administration (FDA), this complication can lead to compromised patient safety and 'may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke and death.'

To date, the Agency has received reports of three deaths and 22 complaints related to balloon rupture or puncture.

Health care professionals and consumers are encouraged to report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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Keywords:ACC Publications, Cardiology Magazine, Health Policy, United States Food and Drug Administration, Patient Safety, Cardiopulmonary Bypass, Risk, Health Personnel, Punctures, Stroke, Embolism

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