Datascope Corp. Recall 88664
Description: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Datascope Corp. Recall 88664 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2615-2021 |
| Event ID | 88664 |
| Event Description | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65 |
| Product Type | Devices |
| Distribution | Nationwide domestic distribution. Foreign distribution worldwide. |
| Quantity | 3969 total (US), 3550 total (OUS) |
| Recall Reason | The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions. |
| Device Classification | 20211006 |
| Device Code Info | All lots |
| Center Classification Date | 20210930 |
| Recall Initiation Date | 20210908 |
| Recalling Firm | Datascope Corp. |
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