July 27, 2023 — Abiomed is recalling the Impella Intravascular Left Sided Blood Pumps because the pump’s Instructions for Use (IFU) do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR). The IFU 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. There is a potential risk that the Impella motor housing may come into contact with the distal stent of a transcatheter aortic valve replacement (TAVR). The contact may damage or destroy the motor’s impeller blades. The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream.  Please be aware, this recall