FDAHealthDecember 4, 2025
Abiomed, Inc. — Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
⚠️ Device packaged in incorrect outer box carton.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- December 4, 2025
International distribution to the country of Australia and Taiwan.
What's affected?
- Product
- Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Brand
- Abiomed, Inc.
- Lot code
- Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;
Additional details
Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6 units.
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