FDA Device recall Z-1030-2026
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU by Abiomed, citing device packaged in incorrect outer box carton.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1030-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-04 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Abiomed |
| Distribution | n/a |
Product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Reason
Device packaged in incorrect outer box carton.
Identifiers
| code_info | Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp.…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1030-2026%22
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