FDA Device recall Z-2967-2024
ImpellaCP SmartAssistSetAPAC, Delo1895
- FDA Device
- Class II
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class II recall of ImpellaCP SmartAssistSetAPAC, Delo1895 by Abiomed, citing A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2967-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-05 |
| Published | 2024-09-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abiomed |
| Distribution | US |
Product
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Reason
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Identifiers
| code_info | Product Code: 1000302; UDI-DI: 00813502012767; Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669;…Product Code: 1000302; UDI-DI: 00813502012767; Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669; Batch Numbers: 2023263121 2023263124 2023263125 2023269641 2023269670 2023269672 2023269673 2023269674; |
|---|
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-2967-2024%22
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