Urgent Safety Notice regarding implantable HeartWare LVAS, HeartWare Inc.
2013.12.23
Product group Active implantable medical devices - artificial hearts
Reference 07555/13
Urgent Field Safety Notice regarding implantable HeartWare LVAS, Models 1100, 1101, 1102, 1103, 1104 and 1205, Serial numbers HW001 to HW11215 and HW20001 to HW20296, of HeartWare Inc., Miami Lakes, Florida, USA, due to possible risk of failing of the locking mechanism of the driveline connector.