Johnson & Johnson’s Abiomed has sent an urgent medical device correction about a malfunction risk linked to 22 reports of ...

The FDA issued an early alert related to updated instructions for certain Impella devices from Johnson & Johnson MedTech’s ...

The agency says there have been 22 injuries and no deaths associated with this potentially high-risk device issue.

More Impella left-sided blood pumps are under Class I recall, this time for potential interactions with transcatheter aortic valve replacement (TAVR) stents, the FDA announced Thursday. The affected ...

A new warning is being issued over a heart pump whose use could perforate the heart. The device has already been linked to over 100 injuries and 49 deaths. These left-sided Impella heart pumps are ...

When he was 25 years old, Thorsten Siess, a mechanical engineering student at the University of Aachen in Germany had an idea: What if there was a way to keep the heart pumping blood during surgery or ...

For Abiomed’s beleaguered family of Impella heart pumps, Class I recalls are becoming a monthly event. The devices have racked up their third recall in as many months, the latest of which focuses on ...

After a 2023 marred by recalls and FDA wrath, Johnson & Johnson subsidiary Abiomed has once again issued a recall connected to its Impella blood pumps. Categorized as Class I, the most recent recall ...

For patients who have acute MI with cardiogenic shock (AMICS), Medicare claims data aren’t detailed enough to show whether use of the Impella percutaneous microaxial left ventricular assist device ...