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

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 ...

Johnson & Johnson’s Abiomed division is once again the subject of a Class I recall for its Impella heart pumps, this time pertaining to a potential safety conflict in patients with transcatheter ...

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 ...

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 ...