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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 v
Recalled August 12, 2015 · FDA recall Z-2264-2015 · Medtronic Cardiovascular Surgery-the Heart Valve Division
Hazard
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. · FDA Class I
Units
6,912 units total (540 units in US)
Sold at
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, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Description
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
Product
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.
Manufacturer(s)
Medtronic Cardiovascular Surgery-the Heart Valve Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →