Johnson & Johnson MedTech Automated Impella Controller (AIC) Wrongful Death Lawsuit Lawyers

Nationwide Concerns Over Automated Impella Controller Device Failures and Potential Legal Claims for Victims

The U.S. Food and Drug Administration (FDA) has classified Johnson & Johnson MedTech’s Automated Impella Controller (AIC) recall as a Class I—the most severe recall level, indicating a high risk of serious injury or death. These devices are designed to display patient data while Impella heart pumps are in use, supporting patients with severe heart conditions during critical procedures. The defect involves connection failures where the controller does not detect a heart pump, resulting in inadequate hemodynamic support. This malfunction has already been linked to at least three patient deaths worldwide.

Details of the Recall and Affected Devices

The recall covers over 11,000 units of the Automated Impella Controller used globally with Johnson & Johnson’s line of Impella heart pumps. While the malfunction is reported to occur in only 0.02% of devices, the consequences can be catastrophic. Healthcare providers were alerted in June 2025, with recommendations to:

• Maintain backup controllers available during use.
• Closely monitor device connections during procedures.
• Report any device issues to the FDA and Johnson & Johnson MedTech immediately.

At this time, no products are being removed from circulation, but the recall underscores urgent safety concerns that require vigilant monitoring.

Potential Injuries Linked to the Impella Controller Malfunction

The failure of the AIC to detect a connected heart pump can cause:

• Insufficient blood circulation during critical care
• Severe organ damage due to inadequate hemodynamic support
• Cardiac complications or failure of life-sustaining therapy
• Prolonged procedures and emergency interventions
• Death in extreme cases where the malfunction is undetected

Patients who rely on Impella heart pumps are already critically ill, making this device defect particularly dangerous.

Legal Options for Patients and Families Harmed by Defective Heart Pump Controllers

Medical device manufacturers are legally obligated to ensure their products are safe and effective. If a defective Impella controller caused harm or contributed to a patient’s death, victims and their families may pursue claims for:

• Medical costs and extended hospital stays
• Additional surgeries or treatments caused by the malfunction
• Pain, suffering, and emotional distress
• Lost wages and diminished earning ability
• Wrongful death damages in fatal cases

Legal action not only seeks compensation for victims but also holds manufacturers accountable for unsafe medical technology.

What to Do If You or a Loved One May Have Been Affected

If you suspect harm related to the use of an Impella heart pump and its controller:

• Request detailed medical records to determine if an affected AIC device was used.
• Document all symptoms, complications, and additional treatments required.
• Speak with an experienced medical device injury attorney to evaluate your potential claim.

Taking prompt action can preserve critical evidence and improve the chances of securing rightful compensation.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one suffered harm or death linked to a defective Johnson & Johnson Impella heart pump controller, you may have a valid legal claim. Parker Waichman LLP is a national personal injury law firm dedicated to helping victims of defective medical devices.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free consultation to discuss your potential case and legal options. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you and provide a free consultation.