Recall archive / FDA device enforcement
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. — FDA record Z-1030-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 4, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Reason
- Device packaged in incorrect outer box carton.
- Classification
- Class II
- Recalling firm
- Abiomed, Inc.
- Quantity
- 6 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1030-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Australia and Taiwan.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 14, 2026
- Recall initiation date
- Dec 4, 2025
- Center classification date
- Jan 8, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.