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Thoratec Warns Of Potentially Lethal Complications When Patients Switch To New HeartMate II Controller

This article was originally published in The Gray Sheet

Executive Summary

Serious adverse events have been linked to patients struggling to switch their Thoratec HeartMate II left-ventricular assist devices from an older controller system to the newer Pocket Controller system. The company is updating the labeling and training materials for the system and warning doctors and patients to communicate to ensure they understand how to convert to the Pocket Controller.

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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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Health care providers treating patients with a Thoratec HeartMate II left-ventricular assist device should not let the patients switch to the new Pocket Controller until they are completely trained on how to hook-up the new system, experts familiar with the devices say. Ideally, the patients will come into the physician’s office to make the switch.

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