FDA recall Z-0995-2020

Product

GORE¿ EXCLUDER¿ AAA Endoprosthesis

Reason for recall

Firm has received reports of leading end catheter component separations.

Distribution

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;

Key facts

Status

Terminated

Initiation date

2020-01-06

Report date

2020-02-12

Termination date

2022-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0995-2020