Impella Rp Flex With Smartassist. Product Code: 1000323.
- Recalling firm
- Abiomed, Inc.
- Product
- Impella RP Flex with SmartAssist. Product Code: 1000323.
- Reason
- Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- Classification
- Class III
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-27
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/dac00037-a0e8-4555-a04a-905264f75329