Impella devices have been the subjects of a series of Abiomed letters and FDA early alerts and recall notices. In January, Abiomed sent an urgent medical device correction about a malfunction risk ...
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 ...
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 ...
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 ...
Ocala Regional Medical Center has introduced new minimally invasive technology that helps patients' heart pump blood during surgery. Ocala Health — which includes the medical center and West Marion ...
A pricey high-tech pump that maintains blood flow during heart procedures could be more dangerous to patients than its low-tech predecessor, a pair of new studies finds. The Impella device is ...
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 ...