Recall archive / FDA device enforcement
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump — FDA record Z-2319-2024
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 May 31, 2024. 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 CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
- Reason
- Nine (9) Impella CP pumps failed inspection and were inadvertently released.
- Classification
- Class I
- Recalling firm
- Abiomed, Inc.
- Quantity
- 9 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2319-2024
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 | Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic only: FL, MA, OH TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 24, 2024
- Recall initiation date
- May 31, 2024
- Center classification date
- Jul 17, 2024
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.