W. L. Gore & Associates Inc. recalls GORE¿ EXCLUDER¿ AAA Endoprosthesis

Recalled February 12, 2020 · FDA recall Z-0995-2020 · W. L. Gore & Associates

Hazard

Firm has received reports of leading end catheter component separations. · FDA Class II

Units

255861 units

Sold at

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;

Description

Firm has received reports of leading end catheter component separations.

Product

GORE¿ EXCLUDER¿ AAA Endoprosthesis

Manufacturer(s)

W. L. Gore & Associates Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →