Impella Heart Pump Controller Problems May Be Linked to 3 Deaths: FDA

Abiomed issues updated instructions as regulators investigate life-threatening device malfunction.

Federal health officials have issued a safety warning regarding potential malfunctions with Abiomed’s Automated Impella Controller (AIC), following reports that the device may have contributed to at least three patient deaths.

The U.S. Food and Drug Administration (FDA) issued an early alert on July 1, warning that the AIC may fail to detect Impella heart pumps when connected, which could compromise critical blood flow support and increase the risk of serious injury or death. 

Impella heart pumps are small, temporary devices inserted into the heart’s left ventricle through a blood vessel, often used in patients with severe heart failure or during high-risk cardiac procedures. The AIC acts as the user interface, displaying real-time data and controlling pump function.

If the controller fails to detect the pump, particularly during startup or when transferring between consoles, it can result in dangerously low blood flow. Compounding the risk, the device does not issue a visual alarm when this detection failure occurs.

Impella Heart Pump Issues

The warning about the Impella controller adds to a growing list of safety concerns surrounding Abiomed’s heart pump devices. In 2024, the FDA issued a Class I recall for Impella Left Sided Blood Pumps due to a risk of heart wall perforation, an issue tied to at least 49 deaths and 129 injuries. 

That same year, another recall impacted the Impella 5.5 with SmartAssist model, citing problems with purge fluid leaks and valve damage.

In 2023, a separate Class I recall was issued for the Impella RP Flex catheter, after the FDA found the device failed to adequately warn about the risk of blood clots. At least 12 injuries were reported in connection with that issue.

These repeated safety concerns have fueled a series of Impella heart pump lawsuits filed by patients and families, including at least two wrongful death claims involving patients who suffered fatal internal injuries allegedly caused by an undetected device malfunction during procedures.

Automated Impella Controller Warning

The current warning affects more than 11,000 Automated Impella Controller (AIC) devices in use worldwide. A complete list of impacted models is included in the FDA’s early alert.

On June 23, Abiomed issued letters to affected customers, warning that certain AIC units may fail to detect a connected Impella heart pump, a critical malfunction that could pose serious risks during patient care.

The detection failure can occur either at the initiation of therapy or during a console transfer. Compounding the danger, the AIC does not display a visual alarm when the issue occurs, leaving clinicians unaware that the pump may not be functioning properly.

This malfunction can result in inadequate blood flow support, particularly for patients in cardiogenic shock, a life-threatening condition in which the heart fails to pump enough blood to meet the body’s needs. Any delay in restoring proper pump function may lead to severe complications or death.

While no serious injuries had been reported as of June 13, the malfunction has been linked to at least three patient deaths.

In its safety notice, Abiomed advises healthcare providers to keep a backup controller readily available and to inform all relevant departments and facilities of the potential risk and the FDA’s alert.

Customers with concerns or adverse event reports can contact Abiomed at 978-646-1400.

Adverse reactions may also be reported to the FDA through its MedWatch Safety Information and Adverse Event Reporting Program.

Impella Heart Pump Lawsuits

Amid the growing number of Impella recalls issued in recent years, Impella heart pump recall lawyers are investigating cases for individuals who have received the devices and experienced any of the following injuries:

Lawyers provide free consultations and claim evaluations to help individuals throughout the United States determine whether financial compensation or settlement benefits through an Impella heart pump lawsuit may be available.