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 ...

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 ...

DANVERS, Mass.--(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart ...

Certain Automated Impella Controllers (AICs), the main control interface for the Impella catheter (Abiomed/Johnson & Johnson MedTech), should not be used after another issue potentially affecting pump ...

ATLANTA -- Routine use of the Impella CP microaxial flow pump significantly improved survival in patients with infarct-related cardiogenic shock, the randomized DanGer Shock trial showed. In more than ...

Abiomed, part of Johnson & Johnson MedTech, has identified an issue that may affect the detection of its Impella pumps when connected to their controllers, according to an alert put out by the US Food ...

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 ...

Abiomed has issued a warning about an issue with its Automated Impella Controller devices following a reported patient death. The issue stems from a manufacturing defect in certain units’ pump driver ...

A new high-tech help for young heart patients has been approved by the U.S. Food and Drug Administration. Doctors say this will allow them to save more lives, an important milestone as we kick off ...