Z-1030-2026 Class II Ongoing
FDA device recall Z-1030-2026 was initiated by Abiomed, Inc. on December 4, 2025 and is designated Class II. Reason for recall: Device packaged in incorrect outer box carton. The recall status is ongoing. Affected quantity: 6 units.
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;