Medtronic has stopped the distribution and sale of the HVAD™ System as of June 3, 2021 and has notified physicians to cease new implants of the HVAD System and transition to an alternative commercially available left ventricular assist devices (LVAD) for all future implants. Replacement of the HVAD System is not recommended at this time for patients who currently have the device because, in the vast majority of cases, the risks associated with additional surgery outweighs the benefit of a replacement device. If you have questions about this, please contact your healthcare provider.
Medtronic initiated this action in light of a growing body of observational clinical comparisons demonstrating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD™ System as compared to other commercially available LVAD.
In addition, Medtronic previously made an Urgent Medical Device Communication informing physicians that the HVAD pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death.
Considering these findings and the availability of alternative devices, Medtronic made the decision to stop the distribution and sale of the HVAD System, consistent with its commitment to prioritize patient safety.
Medtronic is doing everything possible to minimize any risks to your health. We previously provided the recommendations below to your VAD Clinical team, and we want to make sure you also have this information about our commitment to supporting you:
In addition to speaking with your clinician, you may call the Medtronic Hotline at 1-800-635-3930 with questions about your HVAD device, including financial assistance for certain medical expenses.
Medtronic remains committed to supporting patients living with the HVAD System, as well as the caregivers who participate in their care, by continuing to provide resources designed to aid and assist them. MEDTRONIC IS STILL WALKING BESIDE YOU.
Information for Patients
As part of this commitment to patients, we will continue to share important safety information about the Medtronic HVAD™ System. Patient advisory letters that are mailed to HVAD patients will be posted and available here.
There is nothing more important to Medtronic than the safety and well-being of patients. Although we have stopped distribution and sale of the HVAD™ System, we are committed to serving the needs of the approximately 4,000 patients currently implanted with the device globally. For more information about left ventricular assist devices and the HVAD System, please reference the HVAD Learning Center.
In consultation with an independent panel of clinician advisors, we have developed patient management recommendations and a support program for these patients, their caregivers, and the clinicians who participate in their care. The program includes:
Medtronic has been working with the FDA and other global regulators to ensure that patients and their clinicians have information about this patient and provider support program. We are committed to supporting them to ensure they have access to the best available guidance and resources.