W. L. Gore & Associates Inc. recalls GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)

Recall date: January 6, 2020
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-0996-2020
FDA classification: Class II
Brand / firm: W. L. Gore & Associates Inc.
Sold / distributed: 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; Net…

Why it was recalled

Firm has received reports of leading end catheter component separations.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)

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