The Food and Drug Administration (FDA), on July 27, identified the recall by Abiomed of all Impella Left Sided Blood Pumps as Class I, the most serious.
Abiomed is recalling the pumps because the instructions for use do not adequately address precautions to take when treating transcatheter aortic valve replacement (TAVR) patients. There is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, and the contact may damage or destroy the motor’s impeller blades.
The damaged system may have reduced blood flow or pump stop, which may fail to provide enough support to the patient, and there is the risk that pieces of the broken blades could enter the patient’s blood stream.
The pumps are not being removed from the field and do not need to be returned. Clinicians may continue to use the pumps, keeping in mind the additional instructions for patients with TAVR.
The company reports 30 complaints, 26 injuries, and 4 deaths related to this issue.
Distribution dates were May 1, 2021, to present.Read More >>