Temporary Non-Roller Type Right Heart Support Blood Pump

FDA product code PYX · Class III (high risk) · 21 CFR 870.4360 · Cardiovascular

Providing temporary partial or full right heart circulatory support.

0510(k) clearances
1PMA approvals
7recalls

PMA approvals

Recalls

RecallProductFirmInitiated
Z-1471-2026 Class IImpella RP. Product Code: 0046-0011.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Abiomed, Inc.01/27/2026Open, Classified
Z-1470-2026 Class IImpella RP Flex with SmartAssist. Product Code: 1000323.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Abiomed, Inc.01/27/2026Open, Classified
Z-1469-2026 Class IImpella RP with SmartAssist. Product Code: 0046-0035.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. Abiomed, Inc.01/27/2026Open, Classified
Z-0830-2025 Class IImpella RP Flex with SmartAssist; Product Number: 1000323;Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting… Abiomed, Inc.12/12/2024Open, Classified
Z-0829-2025 Class IImpella RP with SmartAssist; Product Number: 0046-0035;Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting… Abiomed, Inc.12/12/2024Open, Classified
Z-0636-2024 Class IIImpella Connect, software portal for online device management that allows clinicians and…The following features have been disabled from the web-based portal because the FDA has not evaluated these… Abiomed, Inc.12/06/2023Open, Classified
Z-2281-2023 Class IImpella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number…A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus… Abiomed, Inc.06/29/2023Open, Classified