Datascope Corp. Recall 91652
Description: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp. Recall 91652 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1277-2023 |
| Event ID | 91652 |
| Event Description | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 |
| Product Type | Devices |
| Distribution | Distribution list not yet provided. |
| Quantity | 391 total IABPs |
| Recall Reason | There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy. |
| Device Classification | 20230329 |
| Device Code Info | Model Number: 0998-00-0800-75, UDI-DI: 10607567112312; Model Number: 0998-00-0800-83, UDI-DI: 10607567108407; Model Number: 0998-00-0800-85, UDI-DI: 10607567113449; Serial Numbers: CA237026J3 CH231276C6 |
| Center Classification Date | 20230322 |
| Recall Initiation Date | 20230228 |
| Recalling Firm | Datascope Corp. |
| Initial Notification | Letter |
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