The U.S. Food and Drug Administration (FDA) has issued an early alert about a potentially life-threatening defect involving Abiomed’s Automated Impella Controller (AIC)—a critical component in the company’s widely used blood pump systems. This communication, part of the FDA’s pilot program to improve medical device recall transparency, underscores serious concerns about device detection failures that may compromise patient safety during high-risk cardiac procedures.

Abiomed’s AIC is a primary interface for its Impella heart pumps, which are used in patients suffering from cardiogenic shock or requiring temporary cardiac support during surgery or recovery. According to the FDA, the malfunction involves the controller’s inability to detect the pump during case startup or when transferring from one console to another—without issuing a visible alarm to alert clinicians. As of June 13, three patient deaths have been reported in connection with the problem.

Source: FDA Medical Device Recall: Abiomed Blood Pump Controller Issue

What Is the Abiomed Impella Device?

Abiomed’s Impella system is a minimally invasive, catheter-based heart pump used to assist circulation during serious cardiac events. It’s most commonly employed in cases of cardiogenic shock or high-risk percutaneous coronary interventions (PCI) where a patient’s heart needs support to continue pumping blood.

At the center of the system is the Automated Impella Controller (AIC)—a computer console that allows medical personnel to operate and monitor the pump. Because of the fragile condition of many patients who rely on these devices, any failure in communication between the controller and the pump can result in rapid deterioration, injury, or death.

What’s the Problem with the Impella Controllers?

According to the FDA’s June 2025 alert, Abiomed notified customers that the AIC may fail to recognize the pump after connection under two key circumstances:

1. Console-to-Console Transfer – When moving a patient’s pump to a new console, the AIC may freeze on the startup screen and fail to detect the device.
2. Case Startup – At the beginning of a procedure, the AIC may stall and not proceed to the “Detecting Impella” stage.

In both instances, no visual or audible alarm is displayed. This silent malfunction puts patients at risk of receiving inadequate hemodynamic support during critical stages of care.

Why This Issue Is So Dangerous

For patients in cardiogenic shock, time is everything. Even short lapses in circulatory support can lead to organ failure, brain damage, or death. The AIC’s failure to recognize the pump—combined with the absence of any warning alert—can cause delays in treatment that result in catastrophic outcomes.

While Abiomed has not issued a full product recall, the FDA has classified the issue as potentially high-risk, citing three known deaths and additional concerns about serious injury.

Abiomed’s Safety Recommendations

On June 23, 2025, Abiomed sent a letter to affected customers advising the following precautions:

• Always have a backup AIC console available in the event of device failure.
• If the startup screen hangs for more than 20 seconds, immediately switch back to the previous console or restart the new one.
• In case of startup delays, clinicians should restart the console or attempt the procedure with a different console entirely.
• Notify all staff and affiliated facilities of the issue, especially if equipment has been transferred between sites.

These mitigation steps require fast decision-making during procedures and place an extra burden on already overextended clinical teams.

Is This a Recall?

No formal recall has been announced yet, but the FDA is actively reviewing the situation and maintaining an open communication channel with the public. This advisory is part of a pilot communications program designed to keep consumers and healthcare providers informed of high-risk safety signals before an official recall classification is finalized.

Legal Implications: What This Means for Patients and Families

At KBD Attorneys, we’ve investigated numerous medical device failures where companies failed to adequately warn or protect vulnerable patients. While Abiomed’s notice advises precautionary steps, the fact remains that a critical life-sustaining device failed silently, contributing to multiple fatalities.

Patients undergoing cardiac procedures are among the most medically fragile. A device failure like this—particularly one with no visible warning system—raises serious concerns about product design flaws, testing failures, and inadequate risk communication.

In product liability and wrongful death cases involving medical devices, potential claims may include:

• Design defects – The failure of the AIC to alert users of detection problems.
• Failure to warn – If the instructions for use or training materials did not adequately inform medical teams of this known risk.
• Negligence – In the event that timely design corrections were delayed or safety warnings were not broadly disseminated.
• Wrongful death – For patients who died due to this malfunction, families may be entitled to damages.

KBD Attorneys: Advocating for Victims of Medical Device Failures

At KBD, our firm has experience representing patients and families harmed by dangerous or defective medical devices, including cardiac implants and assistive technologies. We’re closely monitoring the Abiomed situation and have dedicated resources to investigate the root cause of this failure.

We maintain:

• A dedicated heart device page outlining legal options.
• Regular blog updates on this issue and other heart pump litigation.
• A medical device injury team with experience taking on major manufacturers and recovering compensation for those harmed.

If you or a loved one suffered complications, injury, or loss following the use of an Abiomed Impella pump, particularly during console startup or transfer, you may be eligible for legal action.

How to Report a Problem

If you’re a health care provider or patient who has experienced issues with an Abiomed device, you can:

• Report adverse events directly to the FDA through MedWatch, the Safety Information and Adverse Event Reporting Program.
• Check the AccessGUDID database to identify affected medical devices using the Unique Device Identifier (UDI).
• Contact Abiomed directly at 978-646-1400 with questions or safety concerns.

Final Thoughts

The FDA’s alert on the Abiomed Impella blood pump controller is a reminder of how essential safety systems are in modern medical devices—especially those designed to support patients in life-or-death scenarios. Silent failures without visible alarms should never happen in critical care settings. Until stronger safeguards are implemented, it’s crucial for patients, families, and medical teams to stay informed—and for manufacturers to be held accountable when their devices cause harm.

If you believe you or someone you love was affected by this issue, KBD Attorneys is here to help.

Contact KBD Attorneys today for a free case evaluation or visit our Abiomed Defective Device Page to learn more about your legal rights.