After the FDA handed out a Class I label earlier this month for a recall of miniaturized internal heart pumps developed by Johnson & Johnson’s Abiomed division, an update from the agency has now linked four deaths to the issue.
In recall postings first dated July 14, the FDA detailed how Abiomed’s Impella device—a catheter-based pump threaded into the left side of the heart to help relieve the workload on a weakened heart muscle—can potentially collide with pieces of a patient’s aortic valve replacement.
The stentlike struts along the outer edge of a TAVR implant can enter the side of the Impella pump and collide with its spinning blades, shearing them off and causing parts of the device to fracture. The company previously identified this issue in a safety notice (PDF) sent to healthcare providers in mid-June.
This can result in a potentially dangerous loss of blood flow through the damaged heart pump as well as potentially spreading debris into the patient’s bloodstream, according to Abiomed. A Class I recall is the FDA’s most serious, denoting a higher risk of patient injury or death.
While the company previously noted it had received 27 reports of the issue—which it said add up to about 0.7% of all patients with TAVR implants treated with an Impella system since 2016—the FDA posted a notice July 27 updating that number to 30 complaints, including 26 injuries and four deaths.
The recall spans nearly 7,900 devices distributed in the U.S. since May 2021, according to the agency, including different models and sizes of Impella pumps designed for the left side of the heart, for use during minimally invasive coronary procedures, open-heart surgeries and the treatment of cardiogenic shock following a heart attack.
“The [device’s instructions for use document] lacks guidance to clinicians on how to manage use of Impella in patients with TAVR and fails to describe how the issue may present if an Impella interacts with TAVR,” the agency said in its notice.
The devices do not need to be returned to the manufacturer. Instead, the FDA said the Impella can continue to be used as long as surgeons take note of the updated instructions and make sure the pump is not spinning while it is being repositioned.
In addition, the company and the FDA advised clinicians to replace the Impella pump as soon as possible if they observe any low blood flow while treating a patient with a TAVR implant.