GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Reported: November 4, 2020 Initiated: September 9, 2020 #Z-0291-2021
Product Description
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
Details
- Recalling Firm
- W L Gore & Associates, Inc.
- Units Affected
- 19013 units
- 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
- Location
- Flagstaff, AZ
Frequently Asked Questions
What product was recalled? ▼
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System. Recalled by W L Gore & Associates, Inc.. Units affected: 19013 units.
Why was this product recalled? ▼
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2020. Severity: Moderate. Recall number: Z-0291-2021.
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