[pending] CS300 IABP. Software Version CS300 IABP C.01.
Pending LLM rewrite. Source: FDA_DEVICE Z-1487-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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