Abiomed, Inc. Recall 95129
Description: ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Abiomed, Inc. Recall 95129 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2967-2024 |
| Event ID | 95129 |
| Event Description | ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom. |
| Quantity | 8 units |
| Recall 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. |
| Device Classification | 20240911 |
| Device Code Info | 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; |
| Center Classification Date | 20240904 |
| Recall Initiation Date | 20240805 |
| Recalling Firm | Abiomed, Inc. |
| Initial Notification | Letter |
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