More Impella left-sided blood pumps are under Class I recall, this time for potential interactions with transcatheter aortic valve replacement (TAVR) stents, the FDA announced Thursday. The affected ...
Johnson & Johnson subsidiary Abiomed recalled its Impella left sided blood pumps for risk that the devices could perforate the heart during a procedure. The recall began on Dec. 27 with Abiomed ...
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 ...
ROCHESTER, Minn. — With only a 50% survival rate, the heart attack complication known as cardiogenic shock is one of the direst challenges faced by emergency room and ICU clinicians. A dangerous ...
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 ...