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News From the Food and Drug Administration
September 15, 2015

Adverse Events Linked With LVADs

JAMA. 2015;314(11):1108. doi:10.1001/jama.2015.11142

The 2 FDA-approved implantable left ventricular assist devices (LVADs) currently on the market have been linked with serious adverse events, including stroke and bleeding complications (http://1.usa.gov/1OQwgwX).

Implantable LVADs, which circulate blood throughout the body in patients with advanced heart failure, consist of a blood pump, power pack, and controller. The pump is attached to the heart’s left ventricle and the aorta, while the power pack and controller are connected to the pump but remain outside the body.