There are new and revised warnings about the instructions for use of a certain type of heart pump that could lead to a risk of heart perforation, according to an alert issued by the pump's ...

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 ...

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 ...

Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC). Abiomed identified ...

The labeling for several mechanical circulatory support devices is under a sweeping class I recall due to the risk of left ventricle perforations, the FDA announced Wednesday. While not subject to a ...

The agency faulted the device maker for delayed notice of mounting complications, citing increasing reports of how use of the device perforated the walls of the heart. By Christina Jewett A troubled ...

For circulatory support in cardiogenic shock, the best choice between Impella and intra-aortic balloon pump (IABP) has been controversial. Now, new data is complicating the debate. Presenting at the ...