Thoratec Corp. - HeartMate III Left Ventricular Assist System - Class 1 Recall

HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3TM Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3TM Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3TM LVAS Implant Kit, US 6. HeartMate 3TM LVAS Implant Kit, OUS HeartMate 3"Left Ventricular Assist System: The HeartMate 3 LVAS is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. The LVAD is surgically connected to the patient's circulatory system via an Inflow Cannula placed into the left ventricular apex, and an Outflow Graft anastomosed to the ascending aorta.

Source: Medical Device Recalls - March 23, 2024 Category: Medical Devices Source Type: alerts