W L Gore GORE TAG Thoracic Endoprosthesis Recall: Risk of incomplete deployment during
W L Gore recalls GORE TAG Thoracic Endoprosthesis with serial numbers starting TGE212110. Incomplete deployment during surgery may cause complications. Affected patients should contact the manufacturer for details.
Use caution until it’s fixed
Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
Contact the company
What happened, in plain English
W L Gore is recalling a specific type of thoracic endoprosthesis used in heart surgery due to a risk of incomplete deployment during the procedure. This could lead to serious complications if the device doesn't function properly as intended. Read more at govinfonow.com/recall/72946-w-l-gore-gore-tag-thoracic-endoprosthesis-recall-risk-of.
Source Summary by GovInfoNow · govinfonow.com/recall/72946-w-l-gore-gore-tag-thoracic-endoprosthesis-recall-risk-of · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0048-2018
Cite this page
“W L Gore GORE TAG Thoracic Endoprosthesis Recall: Risk of incomplete deployment during.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72946-w-l-gore-gore-tag-thoracic-endoprosthesis-recall-risk-of. Based on FDA recall #Z-0048-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0048-2018%22&limit=1).
Why it’s dangerous
The device may not deploy completely during surgery, which could cause the procedure to fail or lead to complications like bleeding or damage to blood vessels. This is a risk during the surgical procedure itself, not after the device is implanted.
Who’s affected
Patients who have received the GORE TAG Thoracic Endoprosthesis with the listed serial numbers are affected. Medical professionals who use this device for endovascular procedures are most at risk.
How to tell if you have this one
Check the serial number on the device, which starts with TGE or TGU followed by numbers like 212110, 262610, etc. The device is used for heart surgery repairs of the descending thoracic aorta.
- Brand
W L Gore- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to W L Gore directly for specific instructions on how to handle the recalled device.
How this recall unfolded
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0048-2018 (September 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0048-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.