Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2
- Recalling company
- Abiomed, Inc.
- Product
- Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Reason
- Device packaged in incorrect outer box carton.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 4, 2025
- Reported
- Jan 14, 2026
- Distribution
- International distribution to the country of Australia and Taiwan.
- Status
- Ongoing
- Quantity
- 6 units
- Lot / codes
- 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;
- Company location
- Danvers, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1030-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1030-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.