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Patient Errors On Expiring Batteries Spurs Second Thoratec HeartMate II Recall

This article was originally published in The Gray Sheet

Executive Summary

Thoratec issued an Urgent Medical Device Correction Letter Sept. 14 to all hospitals with patients implanted with HeartMate II Left Ventricular Assist Systems and pocket controllers, following the death of two patients, and one serious injury when patients failed to follow instructions on expiring batteries. It follows a 2014 recall tied to patients' switch to the pocket controllers.

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