Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE) Recalled by W. L. Gore & Associates Inc. Due to Firm has received reports of leading end catheter...
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¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Quantity: 23212 units
Why Was This Recalled?
Firm has received reports of leading end catheter component separations.
Where Was This Sold?
US: OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; Netherlands; Norway; Finland; France; Sweden; Monaco;
About W. L. Gore & Associates Inc.
W. L. Gore & Associates Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report