Abiomed, Inc. Recall 95129
Description: Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Abiomed, Inc. Recall 95129 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2957-2024 |
| Event ID | 95129 |
| Event Description | Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; |
| 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 | 9 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: 0048-0040; UDI-DI: 00813502011739; Serial Numbers: 370089 370091 370090 370074 370093 401804 401805 401811 401806; Batch Numbers: 2023172492 2023172497 2023172494 2023172500 2023172499 2023255511 2023255513 2023255522 2023255514 |
| Center Classification Date | 20240904 |
| Recall Initiation Date | 20240805 |
| Recalling Firm | Abiomed, Inc. |
| Initial Notification | Letter |
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