FDA-Device2026-01-14Class II
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Abiomed, Inc.
Hazard
Device packaged in incorrect outer box carton.
Sold states
International distribution to the country of Australia.
Affected count
2 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1030-2026Don't want to check this manually?
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