Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Pending LLM rewrite. Source: FDA_DEVICE Z-0917-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
The recalled product
- Product
- Cardiosave Rescue. Intra-Aortic Balloon Pump system.
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model No. (UDI): 0998-00-0800-83 (10607567108407)
- ALL SERIAL NO.
Distribution
Distributed nationwide across the United States.
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