The U.S. Food and Drug Administration (FDA) has issued an alert for a 'potentially high-risk' leakage issue with Abiomed's Impella heart pump introducer kits. Abiomed, acquired by Johnson & Johnson, has identified that manufacturing issues can cause the introducer sheath to leak, increasing the risk of significant bleeding at the access site. This issue is particularly dangerous for patients on systemic anticoagulation.
To date, Abiomed has reported eight instances of major bleeding related to this problem. More seriously, three patient deaths have been associated with the leakage issue, although the company has described these as 'contested'. This alert represents the latest in a series of safety concerns and recalls for the Impella product line since Johnson & Johnson's $16.6 billion acquisition of Abiomed.