The QMN Weekly Bulletin
Quality / Medical Devices / Regulatory Affairs / Postmarket Safety

Thoratec Recalls LVAS Pocket Controller After Four Deaths

March 14, 2014
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Four patients died after switching to a new form of controller for Thoratec’s HeartMate II Left Ventricular Assist System, the company revealed in a Tuesday recall announcement, adding the deaths did not involve a product malfunction.
Devices & Diagnostics Letter