Injured By a HeartMate II Implantable Heart Pump? Class I Recall Issued
The US Food and Drug Administration (FDA) has announced the Class I recall of HeartMate II implantable heart pumps over a controller issue, after the devices have been linked to four patient deaths and five serious injuries. 
Thoratec, which manufacturers the device, recalled it last month. The affected devices were distributed to medical providers between August 2012 and this year. The injuries were reportedly tied to “instances in which the patients attempted to swap their HeartMate II LVAS devices from an older controller to the Pocket System Controller.”
“These patients did not receive intensive training on connecting the new controller,” the FDA warning said. “The design differences between the EPC System Controller and the Pocket System Controller require a different approach to how the device is connected. If the controller is not properly connected, the device cannot function.”
The devices reportedly rely on controllers to help power the implant, which circulates blood through the body when the heart is too weak to circulate blood on its own.
Patients with the devices are being advised to speak to their healthcare providers about the recall.
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