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.

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 ...

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 ...

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 ...

Device manufacturer Abiomed has recalled the labeling for various models of its left-sided heart pumps due to the potential for the pump catheter to perforate the left ventricle’s wall, the US Food ...

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 ...