Certain preventable advisory alarms may result in patients deciding to attempt a System Controller exchange.
Thoratec Corporation (NASDAQ: THOR) today issued a voluntary Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II “Pocket” System Controller, as specified in the product Instructions for Use. This backup battery has a 36 month expiration date.
Reports of four deaths and five incidents of loss of consciousness or other symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being originally trained on an older model.
On March 4, 2014, Thoratec Corporation initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller (the “Pocket Controller”).