Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Conformable Thoracic Stent Graft Recalled by W L Gore & Associates, Inc. Due to The incorrect label was placed on both the...
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
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Quantity: 15 stents
Why Was This Recalled?
The incorrect label was placed on both the primary and secondary package.
Where Was This Sold?
International the country of Japan.
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