W L Gore Conformable Thoracic Stent Graft with Active Control System Recall: Delivery
W L Gore recalls conformable thoracic stent grafts with Active Control System due to delivery catheter connection preventing removal. Affected units include specific catalog numbers and all lot numbers. Consumers should contact for details.
Use caution until it’s fixed
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
Contact the company
What happened, in plain English
W L Gore is recalling conformable thoracic stent grafts with Active Control System because the delivery catheter can become stuck during removal. This could prevent proper medical treatment if the device needs to be taken out. Read more at govinfonow.com/recall/64340-w-l-gore-conformable-thoracic-stent-graft-with-active-control.
Source Summary by GovInfoNow · govinfonow.com/recall/64340-w-l-gore-conformable-thoracic-stent-graft-with-active-control · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0291-2021
Cite this page
“W L Gore Conformable Thoracic Stent Graft with Active Control System Recall: Delivery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64340-w-l-gore-conformable-thoracic-stent-graft-with-active-control. Based on FDA recall #Z-0291-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0291-2021%22&limit=1).
Why it’s dangerous
When trying to remove the delivery catheter, the stent graft can become connected, preventing the catheter from being withdrawn. This could block the device from being safely removed, potentially causing complications during medical treatment.
Who’s affected
Patients who have received this specific stent graft device are most at risk. The recall affects medical devices used in thoracic procedures.
How to tell if you have this one
Check for catalog numbers starting with TGM or TGMR followed by numbers and an X (e.g., TGM212110X*). All lot numbers are affected. The product is used in thoracic procedures.
- Brand
W L Gore- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to W L Gore for specific instructions on how to handle the recalled device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0291-2021 (September 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0291-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.