Abiomed issued a letter to affected customers earlier this month on Feb. 18, 2026. It recommended that customers remove certain Impella Purge Cassettes. and Impella RP Pump Sets from where they are used or sold. Affected devices include the Impella RP US Pump Set and the Purge Cassette, 5 Pack.
The purge cassette feature delivers rinsing fluid to the Impella heart pump’s catheter. Purge fluid flows from the cassette, through the catheter to the microaxial blood pump to prevent blood from entering the motor.
Abiomed reports that first-generation purge cassettes face an increased risk of purge leaks. As a result, it elected to remove those devices in markets where it offers the second-generation cassettes.
A purge leak may lead to low purge pressure if it goes unaddressed. This can lead to biomaterial ingress, which may result in an unexpected pump stop. Pump stops can result in a loss of hemodynamic support and potentially lead to patient death.
If a purge cassette leak occurs, a user would see a “Purge Pressure Low” alarm on the Automated Impella Controller (AIC).
As of Feb. 3, 2026, Abiomed reports four serious injuries and no deaths associated with the issue, the FDA notice said.
The company instructed customers to identify and remove all Generation 1 Purge Cassettes from use. If a Generation 2 Purge Cassette is not available and the use of a Generation 1 Purge Cassette is absolutely necessary, they should ensure increased monitoring of the purge system.
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.
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.
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.
Earlier this month, 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.
