Official recall notice
FDA DeviceClass INotable
FDA Recall: Impella RP Flex with SmartAssist. Product Code: 1000323.
- Recall date
- 2026-03-11
- Brand
- Abiomed, Inc.
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Recommended action
What to do
4,496 units
Product description
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.