FDA warns public about Johnson & Johnson heart pump controllers after patient death

May 21, 2026 - 23:59

The U.S. Food and Drug Administration has alerted the public to a fresh safety issue involving Johnson & Johnson MedTech's Automated Impella Controllers, devices used to support heart function during high-risk procedures. The warning follows reports of a patient death linked to the equipment.

According to the agency, the problem stems from a software malfunction that can cause the pump to stop unexpectedly or fail to restart. This interruption in blood flow support poses an immediate risk to critically ill patients. The FDA classified the event as a Class I recall, the most serious type, indicating a reasonable chance that the device could cause serious injury or death.

This latest action adds to a troubling pattern for the Impella system. In 2025 alone, the devices have been tied to five separate recalls. Previous issues included risks of the pump perforating the heart wall, as well as problems with the device's catheter tip. The FDA has not disclosed the total number of units affected by the new warning, but it urged healthcare providers to immediately stop using affected controllers and to follow updated safety instructions from the manufacturer.

Johnson & Johnson has stated it is working on a software update to correct the flaw. The company also advised hospitals to keep backup equipment available in case of a controller failure. Patients currently using the Impella system are encouraged to speak with their doctors about the risks and any alternative treatment options.