FDA-Device2023-07-26Class I
Impella LD intravascular micro axial blood pump, Product Number 005082
Abiomed, Inc.
Hazard
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
Sold states
Worldwide distribution - US Nationwide.
Affected count
9252 units
Manufactured in
22 &, 24 Cherry Hill Dr, Danvers, MA, United States
Products
Impella LD intravascular micro axial blood pump, Product Number 005082
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2113-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief