Abiomed has issued a warning about an issue with its Automated Impella Controller devices following a reported patient death. The issue stems from a manufacturing defect in certain units’ pump driver ...

Johnson & Johnson (NYSE:JNJ) today shared new clinical findings from a novel U.S. pilot study of its Abiomed unit’s Impella 5 ...

Certain Automated Impella Controllers (AICs), the main control interface for the Impella catheter (Abiomed/Johnson & Johnson MedTech), should not be used after another issue potentially affecting pump ...

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 ...

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.

CLEVELAND — Forty-one-year-old Mark Kader is a husband, father of five, registered nurse, and associate clinical consultant for Abiomed, a medical device company. He's passionate about educating ...

On Thursday, Johnson & Johnson’s (NYSE:JNJ) Abiomed said it is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart.

Results from the first randomized trial of Impella pumps during complex stent procedures, published in the New England ...

The issue of faulty Automated Impella Controllers was elevated to a class I recall by the FDA, following five serious injuries. The agency also revised the label for fenofibrates to remove language ...

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 ...