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.
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 ...
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 ...
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 ...
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 ...
The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement.
Physicians forced to make rapid-fire choices, with limited evidence, in acute myocardial infarction complicated by cardiogenic shock (AMICS) finally have what they’ve long been waiting for: positive ...
A new warning is being issued over a heart pump whose use could perforate the heart. The device has already been linked to over 100 injuries and 49 deaths. These left-sided Impella heart pumps are ...
The labeling for several mechanical circulatory support devices is under a sweeping class I recall due to the risk of left ventricle perforations, the FDA announced Wednesday. While not subject to a ...
ATLANTA -- Routine use of the Impella CP microaxial flow pump significantly improved survival in patients with infarct-related cardiogenic shock, the randomized DanGer Shock trial showed. In more than ...
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