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W L Gore & Associates, Inc. recalls GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
Recalled November 4, 2020 · FDA recall Z-0290-2021 · W L Gore & Associates
Hazard
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible · FDA Class II
Units
13860 units
Sold at
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
Description
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
Product
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
Manufacturer(s)
W L Gore & Associates, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →