July 9, 2019
FDA: Class I recall of Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Device
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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