FDA-Device2020-11-04Class II
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
W L Gore & Associates, Inc.
Hazard
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
Sold states
U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom
Affected count
13860 units
Manufactured in
3750 W Kiltie Ln, N/A, Flagstaff, AZ, United States
Products
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0290-2021Don't want to check this manually?
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