Impella, a heart pump system, aims to reduce the work of the heart’s left ventricle. It provides support for the circulatory system so the heart has time to recover. The AIC serves as the primary user control interface for Impella catheters, controlling them and monitoring them for alarms.
According to the FDA, Abiomed issued an urgent medical device recall (correction) notice to affected customers on May 14. They recommended updated use instructions for all AICs as a software error may cause the AIC to restart when used in conjunction with left ventricular Impella devices. The product is not being removed and inventory can continue to be used. Abiomed continues to work on a software update to address the issue.
J&J’s Abiomed unit identified that, when a patient is treated with a left ventricular Impella device and experiences an extended period (>80 minutes) with no residual pulsatility (<12 mmHg on the aortic placement signal), the AIC may be forced to restart due to an internal software error. This can occur with a sudden change in left ventricular pressure during active pressure calculation. Disabling the aortic placement signal and left ventricular pressure display fails to prevent the AIC from restarting.
During a restart, the AIC screen turns black without further alert and the pump stops for a duration of approximately 35 seconds. When this occurs, the patient is not supported by the system and regurgitation via the cannula may occur. After the AIC restarts, the pump automatically resumes at the previous pressure level.
Patients without alternate mechanical support could face an increased risk of serious injury or death as a result of a lack of hemodynamic support. Abiomed reports two serious injuries to date and one death associated with the issue.
Statement from J&J
A Johnson & Johnson spokesperson shared the following statement with MassDevice via email:
Johnson & Johnson is initiating a voluntary device recall (correction) after identifying a potential software issue in a limited number of Automated Impella Controllers (AICs) when used with left ventricular Impella devices.
Importantly, this is not a device removal, and hospitals can continue to use the AIC. Patient safety is our top priority, and we are working closely with impacted hospitals to inform them as we update the software.
Another warning for Abiomed and Impella
Abiomed, which J&J acquired for $16.6 billion in 2022, has faced a handful of regulatory issues related to the Impella platform in recent years.
Last fall, Abiomed reported five serious injuries and no deaths associated with an issue with AIC purge pressure, leading to purge retainer failures, such as cracks. The company determined that the force users apply during purge disc insertion/removal contributes to the purge retainer failures.
That warning came not long after different FDA communications related to the Impella pump controllers. In July 2025, the FDA alerted providers that Abiomed issued updated instructions for use related to all of its AICs. As of June 13, Abiomed had reported no serious injuries and 3 deaths associated with that issue.
In August 2025, the FDA issued another alert for Abiomed instructing customers to remove certain AICs from use or sale. According to an Abiomed spokesperson, the issue affected 69 AICs globally. As of Aug. 12, 2025, Abiomed reported one death and no serious injuries associated with that issue.
In February, the FDA said Abiomed issued an urgent medical device correction to notify affected customers of updated use instructions for all Impella RP with Smart Assist and Impella RP Flex with Smart Assist devices. Later that month, it issued a warning related to Impella purge cassettes.
