Cardiosave Hybrid
Pending LLM rewrite. Source: FDA_DEVICE Z-0931-2026.
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 updates the Vibration and Shock Table to reference the correct standards.
The recalled product
- Product
- Cardiosave Hybrid
- 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 (20)
- 1) Model: 0998-00-0800-31
- UDI-DI: 10607567109053
- Serial Numbers: All
- 2) Model: 0998-00-0800-32
- UDI-DI: 10607567111117
- 3) Model: 0998-00-0800-33
- UDI-DI: 10607567109008
- 4)Model: 0998-00-0800-35
- UDI-DI: 10607567109107
- 5)Model: 0998-00-0800-36
- UDI-DI: 10607567114187
- 6)Model: 0998-00-0800-45
- UDI-DI: 10607567108421
- 7)Model: 0998-00-0800-52
- UDI-DI: 10607567108438
- 8)Model: 0998-00-0800-53
- UDI-DI: 10607567108391
- 9) Model: 0998-00-0800-55
- UDI-DI: 10607567108414
- 10) Model: 0998-00-0800-65
Distribution
Distributed nationwide across the United States.
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