FDA Issues Early Alert on Automated Impella Controller Fixation Issue: What Patients and Hospitals Need to Know

The U.S. Food and Drug Administration (FDA) has issued an Early Alert about a potentially high-risk problem with certain Automated Impella Controllers manufactured by Abiomed, now part of Johnson & Johnson. These devices are used in conjunction with Impella heart pumps to provide life-saving circulatory support for patients with severe heart conditions.

The FDA’s communication is part of a new pilot program aimed at enhancing transparency and public safety in the medical device recall process.

What’s the Issue?

Abiomed identified purge retainer failures in the Automated Impella Controller. The purge retainer can crack due to the force applied during purge disc insertion and removal. When this happens, the device may fail to maintain proper purge pressure or detect the purge disc.

These failures can lead to:

• Errors and alarms during operation

• Interruptions in hemodynamic support

• Pump stops that cause a loss of circulatory support

Because Impella devices are often used in critically ill patients with already compromised heart function, a sudden loss of support poses a serious risk of permanent impairment or death.

As of August 27, 2025, Abiomed reported five serious injuries and no deaths linked to this defect.

Affected Products

Abiomed’s alert affects several models of the Automated Impella Controller, including:

• 0042-0000-US – Impella Controller, Packaged, US

• 0042-0010-US – Impella Optical Controller, Packaged, US

• 0042-0040-US – Optical, AIC, Impella Connect, Packaged, US

• 1000432 – AIC with Impella Connect for ECP

• 1000201 – Double Optical, AIC Impella Connect, Packaged, US

(A full list of affected products is available through the FDA’s device recall page).

What Hospitals Should Do

Abiomed issued a letter on September 16, 2025, advising hospitals to:

• Continue using existing inventory while awaiting service.

• Work with Abiomed’s servicing team to return affected devices for updates.

• Forward the notice to anyone responsible for managing or using the devices.

• Complete and return a response form confirming receipt of the alert.

Abiomed will collect and service the affected devices at its service centers, implementing a design change to correct the purge retainer issue.

Healthcare professionals and consumers are also urged to report adverse events or device quality problems to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Why This Matters

Impella devices are marketed as a lifeline for patients with severe heart disease. They are intended to reduce the workload of the heart’s left ventricle, giving the heart time to rest and recover.

But when the very controller meant to operate the device fails, the consequences can be devastating. Even a short interruption in support can mean the difference between survival and catastrophic injury.

This latest issue underscores ongoing concerns about medical device safety and the need for stronger accountability when design flaws put patients at risk.

KBD’s Past Coverage of Impella Safety Concerns

At KBD Attorneys, we have been following Impella device recalls and safety alerts closely. Previous recalls have included firmware errors and catheter-related hazards, all highlighting the high-stakes risks patients face when these devices malfunction.

This latest alert continues a troubling trend: even widely used, FDA-cleared devices can pose unexpected dangers when design flaws go undetected until after patients are already exposed.

Related Reading: FDA Inspection of the Impella Connect , Impella Heart Pump Recall – Perforated Left Ventricular Wall, The Impella Device – The Impella Heart Pump, Impella Recall and Impella Lawsuit

Patient Safety and Legal Rights

Patients and families affected by defective medical devices often face overwhelming challenges—serious injuries, long hospitalizations, or even wrongful death. When these tragedies occur, hospitals and device manufacturers may try to minimize responsibility.

At KBD Attorneys, we represent patients and families harmed by defective medical devices, including heart pumps and controllers like the Impella system. Our mission is to hold manufacturers accountable and to fight for those who suffer when corporations put profits over patient safety.

Learn More: Medical Device Liability Page

Bottom Line

The FDA’s early alert about the Impella Controller purge retainer fixation issue is a reminder that even advanced life-support technology can fail—and when it does, patients pay the price. KBD Attorneys will continue monitoring this recall and providing updates as more information becomes available.