J&J’s Abiomed and manufacturing partner Oscor warned of a bleeding risk from devices used to introduce catheters to the body.

Abiomed has reported eight instances of major bleeding, with three ‘contested’ patient deaths related to a leakage issue with ...

The US Food and Drug Administration today issued an early alert to warn of the possibility that the differential pressure sensor can malfunction in Impella RP with SmartAssist and Impella RP Flex with ...

Adding another layer to Abiomed’s challenging last few months connected to its Impella heart pumps, FDA has updated the device’s Class I recall regarding a potential conflict in patients with ...

Abiomed has issued an urgent medical device correction for its Impella RP and Impella RP Flex series of heart pumps. In a letter sent to customers on January 27, Abiomed said the voluntary device ...

Use of two high-risk cardiovascular devices—the Watchman (Boston Scientific) left atrial appendage occluder and the Impella (Abiomed) left ventricular assist device—is highest in the United States ...