Impella Heart Pump Controller Failure Linked to Patient Death, Resulting in FDA Warning

Abiomed has issued multiple Impella heart pump recalls in recent years, following dozens of patient deaths and hundreds of injuries.

Federal regulators are warning the public about more problems with Abiomed’s Impella heart pump, after a patient died due to issues with its automated controllers.

The Impella pump is a small device about the size of a pencil, which is used during open-heart procedures. It is inserted through the femoral artery in the leg and guided into the heart’s left ventricle to assist with circulation by transferring oxygen-rich blood from the ventricle into the ascending aorta, ensuring a steady blood flow to vital organs during surgery.

On August 27, the U.S. Food and Drug Administration issued an Impella heart pump early alert after Abiomed, the manufacturer, sent a letter to customers telling them to stop using certain Automated Impella Controllers last week.

The controllers are the primary interface with the Impella Catheter portion of the heart pump. They monitor the catheter for alarms and control its functions. A failure in the controller may result in transient hemodynamic instability, loss of circulatory support or death.

Abiomed’s field safety notification warned that some of the controllers have a Pump Drive Circuit Assembly that “does not meet current specifications.” The problem was linked to a patient death on August 12, according to the FDA notice.

“These Pump Driver Circuit Assemblies contain 25v-rated tantalum capacitors instead of 35v-rated tantalum capacitors which may lead to decreased pump performance or pump stop and trigger an ‘Impella Failure’ or ‘Impella Stopped. Controller Failure’.”

–  Abiomed Field Safety Notification, August 21, 2025

The problem affects Impella Controllers sold in the U.S., European Union, U.K. and Canada. The units sold in the U.S. have a product code of 0042-000-US, and a UDI-DI number of 00813502010022. A full list of serial numbers is available in the Field Safety Notification.

Customers in the U.S. with questions can contact Abiomed at ra-abm-fieldaction@its.jnj.com. Patients and healthcare providers are encouraged to report any incidents involving the Impella heart pump to the FDA’s MedWatch adverse event reporting program.

A History of Impella Heart Pump Problems

The FDA early warnings often precede a device recall, particularly when they create a risk of serious injury or death. However, Abiomed’s Impella pump has been beleaguered with problems for years.

The most recent recall of Impella RP and Impella RP Flex Heart Pumps with SmartAssist was issued in February, due to the risk of contact between guidewires and other medical instruments, which could cause the heart pump to shut down unexpectedly.

Due to heart ventricle perforations that killed nearly 50 patients and injured about 130 others, another Impella Left Sided Blood Pump recall was issued in March 2023.

That was one of three recalls that year. Another recall was issued for Impella 5.5 with SmartAssist pumps due to purge fluid leaks that led to device malfunctions, heart valve damage and a heightened risk of severe injuries, with 179 related complaints.

Additionally, the FDA issued a Class I recall for Impella RP Flex catheter systems in June 2023, following inadequate safety instructions regarding blood clot risks. The problem was linked to 12 reported injuries.

Following these recalls, lawyers throughout the United States have begun evaluating potential Impella heart pump lawsuits on behalf of individuals and families who allege that the manufacturer was aware of Impella heart pump risks for years, but failed to act, placing a desire for profits over patient safety.