The recall affects nine Impella CP with SmartAssist devices from the lot (lot number: 1798046), which failed inspection. Image Credit: Michael Vi / Shutterstock.

Abiomed has been forced to issue yet another recall for its heart pumps after nine pumps from a failed inspection lot were shipped to customers.

Although there have been no reported injuries or deaths, and none of the devices have been used in patients, the US Food and Drug Administration (FDA) issued a Class I recall – the most serious type of recall. The nine Impella CP with SmartAssist devices from the lot (lot number: 1798046) were retrieved prior to use, according to Abiomed.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The recall follows an urgent voluntary medical device recall (removal) letter issued by Abiomed on 31 May. The pumps under the affected recall “may lead to unexpected pump stops or release of potentially harmful particulates”, as per the FDA.

Johnson & Johnson MedTech acquired Abiomed in November 2022 in a deal worth $16.6bn. Since the acquisition, the division has issued three Class I recalls for the Impella range. In April 2023, the company recalled Impella 5.5 with SmartAssist system due to a fluid leak. The device fault meant that the pump purge sidearm could leak purge fluid and the system could stop pumping.

In July 2023, Abiomed issued a voluntary correction for six products in the Impella range due to insufficient instructions for use in patients with transcatheter aortic valve replacement (TAVR). The following month, the company issued a recall for the labelling of its Impella RP Flex with Smart Assist System Catheter. The incorrect instructions failed to highlight the necessary precautions needed for treating patients whose anticoagulation clotting time is less than the recommended value.

See Also:

The Impella blood pumps have been dubbed as ‘the world’s smallest heart pump’. These are used to maintain blood flow in individuals whose heart isn’t functioning properly in patients with cardiogenic shock following a heart attack, open heart surgery or due to cardiomyopathy.

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.

GlobalData predicts the cardiovascular medical device market will reach $86.5bn by 2030. The left ventricular assist device market will reach $2.24bn by 2033. Abbott’s HeartMate 3 is the current market leader in the field and was approved by the FDA for less invasive implantation using lateral thoracotomy in 2020.

In March, Abbott suffered a setback when it was forced to issue a Class I recall of the HeartMate Touch System. The recall involved more than 1,500 devices in the US distributed between May 2020 and January 2024 and followed eight reported injuries, three of which occurred during surgery.