Abiomed has recalled the labeling for catheters used in its Impella RP Flex with Smart Assist System, the US Food and Drug Administration announced Thursday. The action comes from concern over a lack ...

The Impella line, too, received a coronavirus-related FDA nod last year, in the form of an emergency authorization for use in treating COVID-19 patients with right-side heart failure.

ABIOMED's IMPELLA Recover Devices also include the Recover (R) RD, the smallest right ventricular unloading catheter; and the Recover (R) LD, the smallest left ventricular unloading catheter ...

Cardiac Arrest and Sepsis Patients treated with Impella also had higher rates of cardiac arrest (33.9% vs 26.8%; HR, 1.310; 95% CI, 1.135-1.511; P < .001) and sepsis (14.6% vs 12.3%; HR, 1.410; 95 ...

Abiomed updated warnings on more than 60,000 Impella Left Sided Heart Pumps because the device might cut the wall of the heart’s left ventricle, the FDA said March 21. After 129 serious injuries ...

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 ...

Abiomed sells other pumps under the Impella brand, which are used for different therapeutic reasons. Johnson & Johnson struck a massive $16.6 billion all-cash deal in 2022 to buy Abiomed to boost ...