Abiomed Impella RP Flex recalled as Class I over sensor drift
Abiomed is recalling the Impella RP Flex with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.
- Product
- Impella RP Flex with SmartAssist. Product Code: 1000323.
- Category
- Medical Device
- Distribution
- Distributed nationwide