Medtronic Cardiovascular Surgery-the Heart Valve Division recalls Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the…

Recall date

August 3, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2546-2016

FDA classification

Class II

Brand / firm

Medtronic Cardiovascular Surgery-the Heart Valve Division

Sold / distributed

Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithu…

Why it was recalled

Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.