Abiomed, Inc. Recall 92321
Description: Impella LD intravascular micro axial blood pump, Product Number 005082
Abiomed, Inc. Recall 92321 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2113-2023 |
| Event ID | 92321 |
| Event Description | Impella LD intravascular micro axial blood pump, Product Number 005082 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide. |
| Quantity | 9252 units |
| Recall Reason | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility. |
| Device Classification | 20230726 |
| Device Code Info | UDI-DI: 00813502011227; |
| Center Classification Date | 20230714 |
| Recall Initiation Date | 20230614 |
| Recalling Firm | Abiomed, Inc. |
| Initial Notification | Letter |
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