Reports of 4 Deaths Prompt Thoratec To Warn About HeartMate II Controller

After reports of four deaths and five patient injuries, Thoratec Corporation issued a safety advisory to hospitals regarding the use of its HeartMate II left ventricular device.  The device is implanted in patients with advanced heart failure to help the heart pump blood.  It is connected to an external battery pack and a pocket system controller, which sets off an alarm if the battery is low.  The injuries occurred while patients and caregivers struggled to change to a backup controller from the main system.  Four patients died while five others lost consciousness or suffered decreased blood flow due to difficulty in switching controllers.  Thoratec denies that there are any flaws in the controllers and has not recalled the devices.  Instead, the company provided updated patient handbook information and advised that all patients and their caregivers should be retrained in the switching process.  Eight of the none incidents occurred in patients who had been converted to the pocket controller from an older model and may not have understood the differences between the new and old systems.

[1] Cortez, M. "Thoratec Warns on Heart Device After Four Patient Deaths," Bloomberg News (March 5, 2014).

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