Z-1030-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2026
- Initiation Date
- December 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
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.
Distribution Pattern
International distribution to the country of Australia and Taiwan.
Code Information
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;