FDA 483 - Heartware, Inc. - September 30, 2021

Heartware, Inc. in Miami Lakes, FL, was cited for significant deficiencies across its quality system, particularly in design control, corrective and preventive actions, complaint handling, and medical device reporting. These issues, many of which are repeat observations, led to numerous confirmed complaints, including patient deaths and serious injuries, related to the HVAD™ System's performance and reliability. The inspection highlights systemic failures in ensuring product safety, efficacy, and compliance with regulatory requirements.