FDA-Device2020-02-12Class II
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
W. L. Gore & Associates Inc.
Hazard
Firm has received reports of leading end catheter component separations.
Sold states
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;
Affected count
23212 units
Manufactured in
32360 N North Valley Pkwy, N/A, Phoenix, AZ, United States
Products
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0996-2020Don't want to check this manually?
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