HVADTM SYSTEM Urgent product update

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.

Patient Information Regarding the HVAD™ System

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 Field Safety Notice (FSN) 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 hospitalisation, 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 prioritise patient safety.

Patient safety is our foremost priority. We recognise 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.

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Why is Medtronic stopping the distribution and sale of the HVAD™ System?

Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD™ System as compared to other circulatory support devices available to patients.

In addition, Medtronic previously made an Field Safety Notice (FSN) 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 hospitalisation, and result in death.

I was implanted with the HVAD™ System – am I in danger?

Since the HVAD™ System will no longer be sold/distributed, will Medtronic stop helping me maintain my device?

Should I have my device replaced with another company’s device?

Is there someone at Medtronic I can contact about this?