Abiomed Announces Voluntary Recall to Revise Labeling Instructions for Its Impella RP Flex with SmartAssist, Citing Concerns About Blood Clot Formation. The U.S. Food and Drug Administration (FDA) has designated a Class I recall for Abiomed's Impella RP Flex with SmartAssist device. This is the most severe type of recall, … [Read more...] about Abiomed Impella RP Flex Thrombosis Lawsuit Lawyers