Abiomed, part of Johnson & Johnson MedTech, has identified an issue that may affect the detection of its Impella pumps when connected to their controllers, according to an alert put out by the US Food ...

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 ...

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 ...

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.

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 ...

Hot on the heels of handing down a trio of Class I recall labels this year to safety events concerning certain Abiomed heart pumps, the FDA has gone a step further in its crackdown. The agency issued ...

ABIOMED, Inc.’s ABMD flagship Impella has been proved to significantly increase cardiogenic shock survival and heart recovery in patients. Data exhibits that survival rates have increased from 51% to ...