US Pharma MarketingThe post Abiomed’s Impella heart pump introducer kits linked to leakage issue in FDA alert appeared first on Medical Device Network.
Abiomed’s Impella heart pump introducer kits linked to leakage issue in FDA alert
Abiomed has reported eight instances of major bleeding, with three ‘contested’ patient deaths related to a leakage issue with its Impella introducer kits. Abiomed has reported eight instances of major bleeding, with three ‘contested’ patient deaths related to a leakage issue with its Impella introducer kits. Since its $16.6bn acquisition by Johnson and Johnson Medtech in 2022, Abiomed has faced a slew of issues in relation to its Impella product range. Credit: Piotr Swat / Shutterstock.com The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ leakage issue associated with Abiomed’s Impella heart pump…
Abiomed has reported eight instances of major bleeding, with three ‘contested’ patient deaths related to a leakage issue with its Impella introducer kits.
Source: Medical Device Network