MASSDEVICE ON CALL — The FDA issued it’s highest-risk Class I warning after Thoratec (NSDQ:THOR) recalled its HeartMate II implantable heart pumps over a controller issue that the FDA said was associated 4 patient deaths and 5 serious injuries.
Thoratec initiated the recall early last month, affecting devices distributed from August 2012 through this year, according to the FDA notice.
The patient injury reports were 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," according to the warning. "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 HeartMate II LVAS devices rely on the controllers to help power the implant, which helps circulate blood throughout the body, taking the load off the heart which may be too weak to circulate blood on its own. The defects arose when patients attempted to switch to a newer controller that became available more recently.
Thoratec plans to update its labeling and training materials and has asked patients to undergo new training on use of their devices.
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