Datascope Corp. Recall 88651
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 88651 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0075-2022 |
| Event ID | 88651 |
| 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 | Worldwide distribution - US Nationwide distribution. |
| Quantity | 3969 total (US), 3550 total (OUS) |
| Recall Reason | The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference. |
| Device Classification | 20211013 |
| Device Code Info | All lots |
| Center Classification Date | 20211007 |
| Recall Initiation Date | 20210908 |
| Recalling Firm | Datascope Corp. |
| Initial Notification | Letter |
| Similar To |