FDA announces new recall impacting more than 66,000 Impella heart pumps after 49 deaths

The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling its instructions for certain Impella left-sided blood pumps due to significant safety concerns. New and revised instructions for use (IFU) have been sent to all affected customers.

Abiomed's Impella 5.5 with Smart Assist (pictured above) is one of the heart pumps included in the recall. Image courtesy of Abiomed.

More than 100 patients have been seriously injured as a result of a significant safety concern. The Impella devices can still be used, according to the recall, if customers refer to Abiomed's new and revised instructions for use.