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
Abiomed, Inc. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–20 of 20 recalls
Class IIOngoingZ-1030-2026
Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2
Device packaged in incorrect outer box carton.
Abiomed, Inc.MAJan 14, 2026
Class IOngoingZ-0136-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product…
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Abiomed, Inc.MAOct 29, 2025
Class IOngoingZ-0069-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC)
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Abiomed, Inc.MAOct 15, 2025
Class IOngoingZ-2568-2025
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below brands and product codes. Used with h…
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications.…
Abiomed, Inc.MAOct 1, 2025
Class IOngoingZ-2164-2025
Abiomed, Inc. recalls Automated Impella Controller (AIC)
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Abiomed, Inc.MAAug 6, 2025
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