ARROW INTERNATIONAL Inc. Recall 91021
Description: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
ARROW INTERNATIONAL Inc. Recall 91021 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0431-2023 |
| Event ID | 91021 |
| Event Description | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump |
| Product Type | Devices |
| Distribution | Worldwide |
| Quantity | 81 units |
| Recall Reason | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Device Classification | 20221221 |
| Device Code Info | UDI/DI (01) 0 0801902 05173 8, (01) 0 0801902 05173 9, All Lot/Serial Numbers |
| Center Classification Date | 20221215 |
| Recall Initiation Date | 20221017 |
| Recalling Firm | ARROW INTERNATIONAL Inc. |
| Initial Notification | Letter |
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