FDA-Device2015-08-12Class I
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.
Medtronic Cardiovascular Surgery-the Heart Valve Division
Hazard
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
Sold states
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.
Affected count
6,912 units total (540 units in US)
Manufactured in
1851 E Deere Ave, N/A, Santa Ana, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2264-2015Don't want to check this manually?
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