Impella Purge Cassettes Removed From Use Over Circulatory Support Failures: FDA

Federal regulators warn that leaking or failed Impella purge cassettes have already been linked to at least four serious injuries.

Hospitals and health care providers are being urged to immediately identify and remove certain Impella heart pump purge cassettes from use, amid serious concerns the devices may malfunction and cause serious harm to patients.

The U.S. Food and Drug Administration (FDA) issued an early alert on February 25, indicating that Abiomed’s Impella Generation 1 Purge Cassettes may experience a leak or failure that can interrupt purge flow to the heart pump system, which has already resulted in at least four serious injuries.

The Impella system is a temporary support device used in patients suffering from severe cardiac events or otherwise undergoing high-risk heart interventions. The purge cassette is designed to regulate and maintain purge fluid flow to the pump motor, which is critical for proper device function.

According to the FDA, if the purge cassette fails or leaks, it may cause the system to alarm, shut down or stop providing circulatory support. In patients who depend on the device for support, even a brief interruption may result in serious injury or death.

This is not the first high-profile alert or recall impacting Impella systems in recent years. Prior issues have resulted in a number of families now investigating potential Impella heart pump lawsuits, involving claims that the devices were sold with design defects that may result in heart-wall perforations and other severe complications.

In the new alert, the FDA is advising health care facilities to identify and remove all Impella Generation 1 Purge Cassette units from wherever they are currently in use. Providers are also being instructed to follow the manufacturer’s recommendations for replacement and to closely monitor patients for signs of pump malfunction.

The agency warned that compromised purge flow can lead to thrombus formation, hemolysis and reduced pump performance. In some cases, clinicians may need to urgently replace the cassette or transition the patient to alternative circulatory support.

While the alert does not apply to newer-generation purge cassettes, like the Generation 2, the FDA emphasized that facilities should carefully review inventory and ensure that older components are not inadvertently used.

Patients or family members with concerns about an Impella device should speak with their treating physician about appropriate monitoring and management options.

The communication has been categorized as an early alert, which is issued to inform the public about potential safety issues before regulators have completed a full evaluation. Additional updates are expected as the investigation continues. The FDA indicates it will provide further information as it reviews available data and works with the manufacturer to address the purge cassette issue.

Any U.S. customers with adverse reactions, quality problems or questions may contact Abiomed Inc. at onemd-field-actions@its.jnj.com. Adverse events and other quality concerns may also be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Impella Heart Pump Recalls

In addition to concerns over the devices’ purge cassettes, Impella heart pumps have been subject to numerous warnings and recalls in recent years.

Earlier this month, federal regulators warned that certain devices may display inaccurate flow and positioning data due to a sensor malfunction, which could lead doctors to take unnecessary or inappropriate medical actions. According to the alert, officials have become aware of at least two dozen Impella heart pump injuries.

Federal regulators also announced an Impella RP and Impella RP Flex Heart Pumps with SmartAssist recall in February 2025, due to the risk of contact between guidewires and other medical instruments, which could cause the heart pumps to shut down unexpectedly.

In addition, Abiomed previously initiated a recall of certain Impella left-sided blood pumps in March 2023 after reports tied the devices to nearly 50 deaths and roughly 130 injuries, including cases involving perforation of the heart’s ventricle.

Another recall targeted Impella 5.5 pumps with SmartAssist technology following concerns that purge fluid leaks could cause device malfunctions, damage heart valves and result in serious patient harm, with 179 complaints reported in connection with the issue.

Following these regulatory actions, some patients have begun exploring potential Impella heart pump lawsuits, alleging that Abiomed was aware of safety concerns yet failed to adequately alert physicians and patients.

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