Thoratec Corp.

System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

Due to software and controller systems that results in unexpected pump start or pump stop.

Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.

Small black plastic particle was observed in the left ventricle during implant procedure.

Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection

Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. The problem affects HeartMate 12V SLA Battery Clips including those used for the HeartMate II LVAS and HeartMate XVE systems. If not detected and handled