Impella RP Flex with SmartAssist. Product Code: 1000323.
Pending LLM rewrite. Source: FDA_DEVICE Z-1470-2026.
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
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
The recalled product
- Product
- Impella RP Flex with SmartAssist. Product Code: 1000323.
- Manufacturer
- Abiomed, Inc.
- 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 (1)
- Product Code: 1000323. UDI-DI: 00813502012811.
Distribution
Distributed nationwide across the United States.
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