Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
FDA Recall #Z-1030-2026 — Class II — December 4, 2025
Product Description
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Reason for Recall
Device packaged in incorrect outer box carton.
Recalling Firm
Abiomed, Inc. — Danvers, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 units
Distribution
International distribution to the country of Australia.
Code Information
Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated