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 ...
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 ...
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 ...
Use of two high-risk cardiovascular devices—the Watchman (Boston Scientific) left atrial appendage occluder and the Impella (Abiomed) left ventricular assist device—is highest in the United States ...
DANVERS, Mass., April 04, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart recovery and support technologies, announced today that the Impella 5.5™ heart ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results