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Medtronic Vascular, Inc. recalls Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery Syst
Recalled November 6, 2013 · FDA recall Z-0083-2014 · Medtronic Vascular
Hazard
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU. · FDA Class II
Units
~1000
Sold at
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.
Description
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
Product
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Manufacturer(s)
Medtronic Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →