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

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

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

Continuous airflow measurements during anesthesia monitoring, intensive care treatment, and in clinical and ambulatory environments provide important information for the assessment of ...