The U.S. Food and Drug Administration (FDA) on July 27 announced that Abiomed is recalling all Impella Left Sided Blood Pumps because the device's instructions do not adequately address precautions to take when treating patients who have undergone TAVR.

According to the agency, "There is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR. The contact may damage or destroy the motor's impeller blades."

Of note, clinicians may continue to use the devices with the additional instructions for patients with TAVR in mind, as this recall is a voluntary correction, not a product removal.

For more information and recommended actions for clinicians, access the FDA website.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support

Keywords: ACC Advocacy, United States Food and Drug Administration, Transcatheter Aortic Valve Replacement, Stents, Heart-Assist Devices

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