FDA Device recall Z-2319-2024
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
- FDA Device
- Class I
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class I recall of Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump by Abiomed, citing nine (9) Impella CP pumps failed inspection and were inadvertently released.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2319-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-05-31 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abiomed |
| Distribution | FL, MA, OH, TX |
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.
Identifiers
| code_info | Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 5043…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2319-2024%22
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