July 9, 2019

FDA: Class I recall of Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Device

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration on July 1 identified the recall by Edwards Lifesciences (Irvine, California) of its IntraClude Intra-Aortic Occlusion Device as Class I, the most serious.

The recall was initiated because of a risk of balloon rupture during use in patients undergoing cardiopulmonary bypass.

The company has received 22 complaints associated with balloon rupture or puncture, and three deaths have been reported.

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