FDA 483 - Heartware, Inc. - January 24, 2014

HeartWare Inc. in Miami Lakes, FL, was inspected and received a Form FDA-483 with seven observations. The inspection revealed significant deficiencies in corrective and preventive actions, purchasing controls, design validation, complaint investigations, process validation, software validation, and design transfer procedures. These issues are particularly concerning given multiple reports of patient deaths and serious injuries associated with their HVAD devices, battery failures, and driveline connector problems.