Johnson & Johnson’s Abiomed division has received its second Class I recall designation from the FDA in as many months. The agency’s label is reserved for issues with a heightened risk of injury or death.
After receiving one in June over potential leaks from one model of its miniaturized Impella heart pumps, the devicemaker garnered its second recall classification last week after identifying a potential safety conflict in patients that also have TAVR implants.
Abiomed’s Impella devices are threaded into the heart’s chambers via a catheter, where an impeller spins at rapid speeds to help pump blood and relieve some of the strain on a damaged or recovering cardiac muscle—such as after suffering a heart attack or following coronary bypass surgery.
Among patients who have also previously undergone an aortic valve replacement, Abiomed has identified 27 cases where the stentlike struts along the outer edges of the TAVR implant have connected with the Impella’s spinning impeller, shearing the blades and causing parts of the pump to fracture, according to the company’s letter (PDF) sent to healthcare providers in mid-June.
This can result in a potentially dangerous loss of blood flow through the damaged Impella device as well as the possibility of spreading debris into the patient’s bloodstream, Abiomed said.
The risks of a collision are higher for patients with TAVR valves that are oversized or have under-expanded frames, the company said, where the struts that lead outside the heart are not flush against the wall of the aorta.
According to the company, those 27 cases amount to about 0.7% of all patients with a TAVR implant who have been treated with an Impella system since 2016. While the majority stemmed from the Impella CP pump, the issue can happen with other device models and sizes as well—totaling more than 9,200 distributed units, according to the FDA.
However, the Impella device is not being removed from hospitals and does not need to be returned to the manufacturer at this time. Abiomed said it plans to update the system’s instructions and is urging surgeons to avoid repositioning the Impella device while it is spinning.
“These devices remain available, and Impella technology can continue to be used safely in patients with a previously implanted TAVR valve,” the company said in a statement to Fierce Medtech.
In addition, the company advised clinicians to replace the Impella pump as soon as possible if they observe any low flows while treating a patient with a TAVR implant.
According to Abiomed, June’s notice to healthcare providers was the first communication regarding this issue in the U.S. market; the company previously issued a notification in Europe and updated the Impella’s instructions for use.
J&J closed its $16.6 billion acquisition of Abiomed in December of last year, making it one of the largest medtech deals of 2022.