Medtronic’s recall of its EnVeo R loading system for the CoreValve Evolut transcather aortic valve device has been designated as Class 1 by the U.S. Food and Drug Administration (FDA). The recall was issued last month due to reports of “particulate being observed in a small number of cases,” Medtronic’s CoreValve was first approved in early 2014 for patients at extreme or high risk of open-heart surgery. The device has also since been approved for “valve-in-valve” (VIV) replacement, where a valve is placed within a failing artificial heart valve.
Medtronic received eight complaints associated with this issue, according to a recall letter posted on the website of Germany’s Federal Institute for Drugs and Medical Devices. The particulate was observed during the valve loading procedure in six cases, and observed in the packaged kits in the other two cases. Medtronic notified customers of the recall in an urgent field safety notice, which stated that a blood clot could arise if particulate matter is mistakenly deployed while the Evolut device is being implanted. More Medtronic Core Valve-Related Recall is Deemed A Class I