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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-0291-2021 · W L Gore & Associates
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn. · FDA Class II
Units
19013 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
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
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 →