FDA Announces Edwards LifeSciences Recall of IntraClude Intra-Aortic Occlusion Device

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On July 1, the U.S. Food and Drug Administration (FDA) announced that 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.

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."

According to the FDA, the firm 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, and can do so online, by regular mail or by fax.

Read the FDA press release here.

Keywords: ACC Advocacy, Patient Safety, United States Food and Drug Administration, Cardiopulmonary Bypass, Telefacsimile, Medical Device Recalls, Product Recalls and Withdrawals, Embolism


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