FDA-Device2024-07-24Class I
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Abiomed, Inc.
Hazard
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Sold states
Domestic only: FL, MA, OH TX.
Affected count
9 units
Manufactured in
24 Cherry Hill Dr, Danvers, MA, United States
Products
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2319-2024Don't want to check this manually?
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