Federal regulators have told the public that every Automated Impella Controller in use in the United States is being pulled by its manufacturer, after the device maker reported 37 serious injuries and three deaths tied to a failing internal part. The Food and Drug Administration published the notice on Wednesday as an Early Alert, a designation the agency uses to flag a potentially high-risk device problem while its own review is still underway.
The controller is the console that runs an Impella heart pump, a small catheter-based pump threaded into the heart to take over some of its work during a high-risk cardiac procedure or during cardiogenic shock. Patients on Impella support are among the sickest people in any hospital. They are typically in a cardiac intensive care unit or a cath lab, often sedated, and frequently in the first hours or days after a heart attack, a failed valve, or a complex stent procedure.
