FDA recall Z-0291-2021

Product

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Reason for recall

When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.

Distribution

U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom

Key facts

Status

Ongoing

Initiation date

2020-09-09

Report date

2020-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Flagstaff, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0291-2021