Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 04, 2025 |
| Reported | December 17, 2025 |
| Recalling firm | Datascope Corp. |
| Country / region | United States NJ |
Hazard
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Affected products
- Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Related recalls
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