Recall Z-0290-2021— 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: Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible.
- 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
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
Data sourced from openFDA. This site is unofficial and independent of the FDA.