FDA-Device2024-07-24Class I
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
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-2319-2024More Abiomed, Inc. recalls
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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