The FDA has notified healthcare professionals of a Class 1 recall due to detachment of the bend relief from its intended position around the proximal outflow graft. The detachment may allow the graft to kink or deform, resulting in reduction of blood flow from Thoratec's HeartMate II LVAD (Left Ventricular Assist Device) pump, pump/graft thrombosis or perforation of the outflow graft.
In addition, the metal end of the bend relief may be sharp and cause erosion and cutting of the outflow graft.
This product may cause serious adverse health consequences, including death. The model numbers affected are 103393, 103695, 104692, 104911 and 104912.
According to the FDA, the device labeling has been revised to provide instructions on how to verify the bend relief is fully engaged with the sealed outflow graft at the time of implant and a new caution statement regarding the bend relief connection is included. Clinicians have been instructed to follow the revised instructions for use that clarify the recommended procedure for securing the bend relief to the outflow graft.
The HeartMate II LVAD is indicated for use as a bridge to transplantation in heart transplant candidates at risk of imminent death from non-reversible left ventricular failure, according to the agency. It is also indicated for use in patients with NYHA Class IIB of IV end-stage left-ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for heart transplantation.
The HeartMate II blood pump delivers blood from the dysfunctional left ventricle of the heart to the rest of the body. It is an axial-flow, rotary ventricular assist system and can generate blood flows up to 10 liters per minute (one beat per minute). The device is intended to be used both inside and outside the hospital (e.g., at home) or during transportation of ventricular assist device patients by ground ambulance, airplane or helicopter.