GORE TAG CONFORMABLE Thoracic Stent Graft Recall for Deployment Issue
W L Gore is recalling GORE TAG CONFORMABLE Thoracic Stent Grafts because a secondary deployment fiber attachment prevented completion of deployment via the access hatch.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant medical devices where the probability of serious adverse health consequences is remote but the defect prevents proper device function.
Plain-English summary
W L Gore & Associates, Inc. is recalling 13,860 units of the GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System. The recall covers all lot numbers and specific catalog numbers listed in the agency documentation. The product was distributed nationwide in the United States and in numerous countries internationally, including Australia, Austria, Belgium, Croatia, Cyprus, 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.
The recall was initiated because a secondary deployment fiber was attached to the secondary deployment handle. This attachment made it impossible to complete the deployment of the device via the deployment line access hatch. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients who have received or are considering this device should contact W L Gore & Associates, Inc. for further instructions on how to proceed. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
- Manufacturer
- W L Gore & Associates, Inc.
- Hazard
- Affected units
- 13,860
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Australia
- New Zealand
- J=Japan All lot numbers
Distribution
Distributed nationwide across the United States.
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