FDA-Device2020-11-04Class II
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
W L Gore & Associates, Inc.
Hazard
When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
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
19013 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-0291-2021Don't want to check this manually?
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