Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System Recalled by W L Gore & Associates, Inc. Due to Due to secondary deployment fiber being attached to...

Date: September 9, 2020
Company: W L Gore & Associates, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact W L Gore & Associates, Inc. directly.

Affected Products

GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

Quantity: 13860 units

Why Was This Recalled?

Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About W L Gore & Associates, Inc.

W L Gore & Associates, Inc. has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report