Recall Z-0291-2021— W L Gore & Associates, Inc.
Class II · Ongoing
Class II FDA medical device recall by W L Gore & Associates, Inc., initiated 2020-09-09. FDA's recall record names no specific 510(k) clearance for this event. Product: GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System. Reason: 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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn..
- Recalling firm
- W L Gore & Associates, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-09-09
- Firm location
- Flagstaff, AZ, United States
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
Data sourced from openFDA. This site is unofficial and independent of the FDA.