Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System Recalled by W L Gore & Associates, Inc. Due to Due to secondary deployment fiber being attached to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact W L Gore & Associates, Inc. directly.
Affected Products
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
Quantity: 13860 units
Why Was This Recalled?
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About W L Gore & Associates, Inc.
W L Gore & Associates, Inc. has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report