FDA-Device2013-11-06Class II
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Medtronic Vascular, Inc.
Hazard
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
Sold states
International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Affected count
~1000
Manufactured in
3850 Brickway Blvd, N/A, Santa Rosa, CA, United States
Products
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2014Don't want to check this manually?
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