Device product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Z-1030-2026
Product summary
- Firm
- Abiomed, Inc.
- Event
- Event 98086
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1030-2026
Official wording
Reason: Device packaged in incorrect outer box carton.
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;
Distribution pattern: International distribution to the country of Australia and Taiwan.
Derived failure modes
-
Unknown
Device packaged in incorrect outer box carton.