Related Experiment Video
Updated: Jan 25, 2026
In Vitro Thrombosis Test for Ventricular Assist Devices
Published on: March 21, 2025
Responding to Ventricular Assist Device Recalls: An Ethical Guide for Mechanical Circulatory Support Programs
James N Kirkpatrick1,2, Claudius Mahr1, Jennifer Beckman1
1From the Department of Medicine, Division of Cardiology, University of Washington, Seattle, Washington.
Insights
Mechanical circulatory support (MCS) programs must ethically inform patients about cardiac device recalls. Timely disclosure of risks and impacts on informed consent is crucial for VAD patients and those considering VADs.
Area of Science:
- Medical Ethics
- Cardiovascular Surgery
- Biomedical Engineering
Background:
- Cardiac device recalls, such as the 2018 Abbott HeartMate 3 and Medtronic HVAD events, present significant ethical challenges for Mechanical Circulatory Support (MCS) programs.
- These recalls impact patients with existing Ventricular Assist Devices (VADs), their caregivers, and individuals undergoing consideration for new VAD implantation.
Purpose of the Study:
- To examine the ethical obligations of MCS programs during cardiac device recalls.
- To analyze the implications of recalls on informed consent and shared decision-making processes for VAD patients.
Main Methods:
- Ethical analysis of responsibilities in the context of simultaneous VAD recalls.
- Review of communication protocols and disclosure gaps between manufacturers, MCS programs, and patients.
Main Results:
- MCS programs face a disclosure gap, often learning about recalls after public announcements, complicating timely patient notification.
- Ethical imperatives demand that MCS teams proactively communicate recall information, including risks and management strategies, to all affected patients.
Conclusions:
- MCS programs have a critical ethical duty to ensure transparent and timely communication with patients regarding cardiac device recalls.
- Addressing the disclosure gap and upholding informed consent are paramount for maintaining patient trust and ethical practice in VAD therapy.
Abstract:
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.
Related Concept Videos
01:56Ethics in Research
02:03Anatomy of the Circulatory System
01:22Ethics and Bioethics
01:27Ethical Issues
Ethical Concerns in Healthcare:
01:30Ethical Dilemmas II
01:25Ethical Standards I
The Code of Ethics provisions outline the nurse's duty to the patient, the healthcare team, the profession, and society. The Code's fundamental principles include advocacy,...