Safety Notice for HeartMate II LVAS System Controller, Thoratec Corporation
2010.09.23
Product group Active implantable medical devices
Reference 03165/10
Thoratec Corporation, Pleasanton, CA, USA, has issued an Urgent Field Safety Notice regarding the HeartMate II LVAS System Controller Models 103695, 103693, 103696, 103692, with all serial numbers starting with “EPC”, due to possible risk of damages of power leads and connectors.