Medtronic Cardiovascular Surgery-the Heart Valve Division recalls EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve…

Recall date

July 15, 2015

Source

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

Recall number

Z-2264-2015

FDA classification

Class I

Brand / firm

Medtronic Cardiovascular Surgery-the Heart Valve Division

Sold / distributed

Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar,…

Why it was recalled

Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.