Urgent Safety Notice regarding implantable HeartWare Ventricular Assist System (VAS), HeartWare Inc.
2013.03.04
Product group Active implantable medical devices - artificial hearts
Reference 00883/13
Urgent Field Safety Notice regarding implantable HeartWare VAS, Models 1100, 1101, 1102. 1104 and 1205, of HeartWare Inc., Miami Lakes, Florida, USA, due to possible risk of loosening or separation of parts of the driveline connector.