The US Food and Drug Administration (FDA) has announced a Class I recall, the most serious designation, for Abbott’s HeartMate 3 left ventricular assist device (LVAD) – a mechanical circulatory support device that is used to assist a failing heart to pump oxygenated blood to the rest of the body.

This LVAD has been associated with 81 incidents of blood leakage or unwanted airflow, including 70 injuries and two deaths.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The HeartMate 3 device is widely used as a therapy option in patients with heart failure (HF) who are either waiting for or are deemed ineligible for a heart transplant.

Prior to 2021, shares in the LVAD market were more or less evenly split between Abbott and Medtronic.

However, in May 2021, Medtronic discontinued its HeartWare LVAD System due to a high incidence of neurological adverse events.

Since then, Abbott has consistently had more than a 90% share of the market, dominating the LVAD space.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The unfortunate current situation is that the number of patients with HF requiring heart transplantation far exceeds the number of available hearts.

In 2023, in the US alone, there were more than 7.8 million prevalent cases of HF due to an increasing ageing population, growing at a compound annual growth rate of 2% between 2015 and 2023.

The lack of available hearts for transplantation, in combination with HeartMate 3’s Class I FDA recall, makes the current therapy landscape for HF much more dire.

While monopolising a market is beneficial for any company, fatal situations such as an increasing prevalence of HF and a shortage of available hearts for transplantation warrant the need for other LVAD options.

A promising alternative to HeartMate 3 is Jarvik Heart’s Jarvik 2000. It is currently being used by leading US hospitals as a therapy option in clinical trials.

Interestingly, this is not the first time Abbott’s HeartMate 3 device has received an FDA recall status.

In 2018, the FDA announced a Class I recall for the same device due to the potential occurrence of outflow graft twisting occlusions post-implantation, resulting in adverse events such as low blood flow or clotting.