Impella Heart Pump Warning Issued Over Controller Malfunction Risks: FDA

Warning indicates the Impella heart pump controller malfunction has already been linked to at least two serious injuries and one patient death.

Federal regulators have issued a warning involving Abiomed Impella heart pump controllers, indicating that a software malfunction may cause certain devices to unexpectedly restart during treatment, potentially interrupting life-sustaining cardiac support for critically ill patients.

The U.S. Food and Drug Administration (FDA) issued the Impella heart pump early alert on May 21, stating that the issue affects certain Automated Impella Controllers (AICs) used with left ventricular Impella heart pumps.

As of April 27, Abiomed had reported at least two serious injuries and one death potentially associated with the malfunction.

Impella Heart Pump Recalls

Impella devices are temporary mechanical heart pumps used to support blood circulation in patients experiencing cardiogenic shock or undergoing certain high-risk cardiac procedures. The systems are designed to reduce the workload on the heart and maintain blood flow while the heart recovers.

However, the new warning follows a series of FDA safety alerts and recalls involving Impella heart pumps in recent years, with regulators raising concerns about reduced patient survival, heart injuries and dangerous blood clots.

In 2023, the FDA issued a Class I recall for Impella Left Sided Blood Pumps, the agency’s most serious recall designation, after reports linked the devices to perforations of the heart ventricle. Federal regulators indicated the issue had been associated with at least 129 injuries and 49 deaths.

Later that year, another Impella recall was announced for Impella 5.5 with SmartAssist systems due to purge fluid leaks that could cause device malfunctions, heart valve damage and other serious complications, following 179 reported incidents.

The FDA also announced a Class I recall for Impella RP Flex catheter systems in June of that year, warning that inadequate instructions regarding blood clot risks could expose patients to potentially life-threatening complications. Regulators said the issue had already been tied to at least 12 reported injuries.

In the wake of these and other recalls, attorneys nationwide have begun investigating potential Impella heart pump lawsuits on behalf of patients and families who allege Abiomed knew or should have known about the risks associated with the devices, yet failed to take adequate action to protect users.

Impella Controller Malfunction Risks

According to the FDA, Abiomed sent an Urgent Medical Device Recall correction notice to healthcare providers on May 14, warning that a software issue in some AIC devices may force the controller to reboot under certain conditions.

The correction notice indicates that during a controller restart for the affected devices, the screen may suddenly turn black and the Impella pump can stop functioning for approximately 35 seconds, leaving patients temporarily without circulatory support. During that time, blood regurgitation through the cannula could also occur.

This issue affects the following products:

• Impella Controller, Packaged, US, Product Code: 0042-0000-US, UDI-DI: 00813502010022
• Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US, UDI-DI: 00813502010985
• Optical, AIC, Impella Controller, Pkgd, US, Product Code: 0042-0040-US, UDI-DI: 00813502011401

The problem may occur when a patient supported by a left ventricular Impella device experiences more than 80 minutes of minimal pulsatility, followed by a sudden change in ventricular pressure while the system is operating above support level P-3. Under those circumstances, an internal software error may trigger the AIC to restart.

Replacing the controller with another unit does not resolve the issue since the malfunction is tied to the software behavior itself. Abiomed is reportedly developing a software update intended to address the problem.

The FDA emphasized that the affected controllers are not currently being removed from hospitals or the marketplace, and facilities may continue using the devices while following the updated instructions provided by Abiomed.

U.S. customers who experience adverse events, product quality issues or have questions related to the warning are encouraged to contact Abiomed at OneMD-Field-Actions@its.jnj.com. Healthcare providers and consumers can also report adverse events or quality problems to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Impella Heart Pump Lawsuits

As the number of Impella recalls and FDA safety warnings continues to grow, Impella heart pump recall lawyers are reviewing potential claims for patients who experienced serious complications after receiving the heart pump devices, including:

Attorneys offer free consultations and case evaluations to help patients and families determine whether they may qualify for financial compensation through a product liability lawsuit or settlement claim.

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