Impella Rp. Product Code: 0046-0011.

Recalling firm
Abiomed, Inc.
Product
Impella RP. Product Code: 0046-0011.
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/a0788bf4-8e7a-4f41-89d4-21f3e4db6421