Responding to Ventricular Assist Device Recalls: An Ethical Guide for Mechanical Circulatory Support Programs

We discuss the ethical responsibilities of mechanical circulatory support (MCS) programs in the context of cardiac device recalls, particularly the near-simultaneous recalls of Abbott HeartMate 3 left ventricular assist device (VAD) and Medtronic HVAD devices in 2018. We consider MCS programs' ethical responsibilities toward patients who already have VADs and their caregivers, as well as the impact of recalls on informed consent and shared decision-making in patients under consideration for new VADs. Timely communication to affected patients is imperative throughout the recall process. MCS programs are required to notify existing VAD patients about the nature and likelihood of risk. A press release from the device manufacturer or other press reports may occur before MCS teams learn about the recall. This leads to a disclosure gap, where the programs are actively deciding on an appropriate action plan while simultaneously fielding patient concerns. From an ethics standpoint, if all device users are owed the recall information from the manufacturer, all patients are owed the information from their treating team. The question is what to disclose specifically, and how.