HeartMate Heart Device Controllers Under Class I Recall After 26 Deaths

(May 24, 2017, 10:45 AM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on May 23 said Abbott-Thoratec has issued a Class I recall of its HeartMate II LVAS (left ventricular assist system) controller after receiving reports of 19 injuries and 26 deaths associated with the heart device....

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