The pumps, left-sided Impella heart pumps made by Johnson & Johnson MedTech’s Abiomed, have been linked to more than 100 serious injuries, including 49 deaths.
An alert was issued by the pump’s manufacturer and posted on the US Food and Drug Administration’s website.
The Impella left-sided heart pumps are used to reduce the work of the heart and support the circulatory system during high-risk cardiac procedures.
The alert is identified by the FDA as a Class I recall, the most serious type of action that the agency can take when a device “may cause serious injuries or death.”
Faculty experts at the George Washington University are available to offer insight on this alert and how this product works. To schedule an interview with an expert, please contact Katelyn Deckelbaum at [email protected].
Ramesh Mazhari, is an associate professor of medicine at GW School of Medicine and Health Sciences. She specializes in interventional cardiology, cardiac catheterization and peripheral vascular disease. Her clinical interests include management of patients with coronary disease, peripheral vascular disease, hemodynamic studies, congestive heart failure and valvular heart disease. As a physician who uses the heart pump, she can explain how it works.
Christian Nagy, is board-certified in internal medicine, cardiovascular disease, interventional cardiology and adult congenital heart disease. He's a practicing cardiologist and an assistant professor at the GW School of Medicine and Health Sciences. He can comment on the alert and how the pump is used.
-GW-