Abiomed Impella Pump Recall

Abiomed has recalled its Impella Left Sided Blood Pumps because the device’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,” a recall notice says. “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).” Such contact may damage/destroy the motor blades, it says.

According to the recall notice, a damaged Impella may lead to reduced blood flow or pump malfunction, which may delay therapy. There is also a risk that broken blade pieces could enter a patient’s bloodstream. Abiomed has reported 30 complaints, 26 injuries, and four deaths associated with the issue.