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 ...

Add Yahoo as a preferred source to see more of our stories on Google. The Food and Drug Administration issued an early alert for a correction of Abiomed's Impella RP Flex heart pumps. (Courtesy of ...

Johnson & Johnson’s Abiomed has asked customers to quarantine certain Impella devices over a risk linked to four serious injuries, the Food and Drug Administration said Wednesday. Abiomed wrote to ...

SALT LAKE CITY, March 11, 2025 /PRNewswire/ — In a transformative recent study, the Second Heart Assist Inc. Whisper™ device, a next-generation percutaneous mechanical circulatory support (pMCS) ...

The Food and Drug Administration (FDA) has issued a Class I recall, the highest-level alert, for heart pumps that have been linked to nearly 50 deaths. Impella heart pumps are used for short term ...

A new life-saving technology was used during a heartfelt reunion thanks to the world’s smallest heart pump, Impella, giving patients a second chance at life ...

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 ...

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 ...

Abiomed identified an issue where the AIC may fail to detect an Impella pump when connected. This pump detection issue can occur during console-to-console transfer or at the start of a case.