Datascope Corp. Recall 91645
Description: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Datascope Corp. Recall 91645 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1230-2023 |
| Event ID | 91645 |
| Event Description | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 |
| Product Type | Devices |
| Distribution | US Nationwide. Global Distribution. |
| Quantity | 8909 units |
| Recall Reason | There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir. |
| Device Classification | 20230315 |
| Device Code Info | All Serial Numbers. 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 |
| Center Classification Date | 20230306 |
| Recall Initiation Date | 20230207 |
| Recalling Firm | Datascope Corp. |
| Initial Notification | Letter |
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