Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Recall date
- December 4, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1030-2026
- FDA classification
- Class II
- Brand / firm
- Abiomed, Inc.
- Sold / distributed
- International distribution to the country of Australia and Taiwan.
Why it was recalled
Device packaged in incorrect outer box carton.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
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