Heart Pumps Recalled Over Controller Issue


According to the US Food and Drug Administration (FDA), a Class I recall of HeartMate II implantable heart pumps over a controller problem has been issued, after the devices have been linked to four patient deaths and five serious injuries.

The injuries reportedly included “instances in which the patients attempted to swap their HeartMate II LVAS devices from an older controller to the Pocket System Controller.”

The controllers at issue reportedly help power the implant, which circulates blood through the body when the heart is too weak to circulate blood on its own.

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