Impella Rp With Smartassist. Product Code: 0046-0035.
Impella RP with SmartAssist Recall Summary Abiomed is recalling Impella RP devices with SmartAssist (Product Code: 0046-0035) because a pressure sensor in the device may malfunction and provide inaccurate readings. This is classified as a Class III recall. The recall affects patients who have received this specific model of the Impella RP heart pump device.
- Recalling firm
- Abiomed, Inc.
- Product
- Impella RP with SmartAssist. Product Code: 0046-0035.
- 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/52c7ab92-e432-4723-9209-77731a59a928