FDA DevicesClass II
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Published: January 14, 2026Recall ID: Z-1030-2026Category: devicesCountry: US
Reason for Recall / Hazard
Device packaged in incorrect outer box carton.
Product Description & Identification
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Additional Source Details
| Field | Value |
|---|---|
| City | Danvers |
| State | MA |
| Event id | 98086 |
| Address 1 | 22 Cherry Hill Dr |
| Code info | 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; |
| Postal code | 01923-2575 |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 6 units |
| Reason for recall | Device packaged in incorrect outer box carton. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251204 |
| Initial firm notification | Letter |
| Center classification date | 20260108 |
Overview
- Recalling FirmAbiomed, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution to the country of Australia and Taiwan.