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 ...
DANVERS, Mass.--(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart ...
The family of the first patient in Yorkshire to successfully receive a new miniature heart pump have thanked cardiologists at ...
Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC). Abiomed identified ...
The family of the first patient in Yorkshire to successfully receive a new miniature heart pump have thanked cardiologists ...
Abiomed has issued a recall alert after identifying a cybersecurity risk with its Automated Impella Controllers. In an Oct. 1 alert to customers, the manufacturer directed users to disable the ...