FDA: Class I recall of HeartMate II LVAS Pocket System Controller

Editor's Note

The Food and Drug Administration (FDA) on May 23 identified the recall by Abbott-Thoratec (Pleasanton, California) of its HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller as Class I, the most serious.

Abbott-Thoratec has receives 70 reports of incidents in which the controller malfunctions after an exchange, including 19 injuries and 26 deaths.

The Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead under the skin.

Posted 05/23/2017] AUDIENCE: Cardiology, Risk Manager, Nursing, Patient ISSUE: Abbott-Thoratec has received a total of 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital.