Class IOngoingZ-1471-2026
Abiomed, Inc. recalls Impella RP. Product Code: 0046-0011.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.MAMar 11, 2026
Temporary Non-Roller Type Right Heart Support Blood Pump recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–5 of 5 recalls
Class IOngoingZ-1470-2026
Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.MAMar 11, 2026
Class IOngoingZ-1469-2026
Abiomed, Inc. recalls Impella RP with SmartAssist. Product Code: 0046-0035.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.MAMar 11, 2026
Class IOngoingZ-0830-2025
Abiomed, Inc. recalls Impella RP Flex with SmartAssist
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Art…
Abiomed, Inc.MAJan 22, 2025
Class IOngoingZ-0829-2025
Abiomed, Inc. recalls Impella RP with SmartAssist
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Art…
Abiomed, Inc.MAJan 22, 2025