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

The study demonstrated Impella ECP's safety and efficacy for use in high-risk PCI. Operators chose 8Fr Angio-Seal as the first-closure method in 70% of the patients, with a 92% success rate 1.

The FDA has issued an early alert warning of a potentially high-risk issue affecting certain Abiomed heart pumps. The agency said Abiomed issued an urgent medical device correction Jan. 27 for all ...

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

Abiomed has issued a “device correction” for all types of its Impella left-sided mechanical circulatory support devices because the pumps’ labeling does not fully address the precautions needed when ...

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

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 ...

Abiomed is recalling all Impella left-sided blood pumps in the US over a potential safety issue when used in patients with a transcatheter aortic valve replacement (TAVR) stent ― something that is not ...

DANVERS, Mass. – October 28, 2024 – Results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference from the first completed pivotal trial on patients supported with Impella ...