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 Medtronic HVAD™ System and transition to an alternative commercial LVAD for all future implants. Prophylactic explant of the HVAD™ System is not recommended at this time.
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 left ventricular assist devices (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.
Patient safety is our foremost priority. We recognize this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them, in coordination with their physicians.
We know the greatest commitment Medtronic makes to patients and their healthcare providers is to consistently make safe and effective devices that alleviate pain, restore health, and extend life. As Medtronic delivers new innovative medical technology for the future, we will continue to embrace our responsibility as a leader in the development and manufacture of safe and effective lifesaving medical technologies.
In consultation with an independent panel of practitioners, Medtronic does not recommend that you have your HVAD™ device removed or replaced, as risks associated with explanation may outweigh the potential benefits. The decision whether to explant and exchange the HVAD™ device should be made by physicians on a case-by-case basis, considering the patient’s clinical condition and surgical risks. If a physician determines that pump exchange is appropriate, we recommend exchanging to an alternative commercial LVAD.
It is important that you and your doctor review your personal situation together and determine an appropriate plan for you and your treatment moving forward.
Your doctor is the best resource for you to ask about your Medtronic device and what it may mean to you and your treatment.