CS300 IABP. Software Version CS300 IABP C.01.
Pending LLM rewrite. Source: FDA_DEVICE Z-1487-2026.
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 firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
The recalled product
- Product
- CS300 IABP. Software Version CS300 IABP C.01.
- 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 (3)
- All Model No
- All UDI
- All Serial No.
Distribution
Distributed nationwide across the United States.
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