W L Gore Thoracic Branch Endoprosthesis Side Branch Component Recall: Catheter Separation
W L Gore recalls specific Thoracic Branch Endoprosthesis Side Branch Components (TSB081006A, TSB081206A, etc.) due to catheter separation risk. Affected units include certain model numbers sold in US, Canada, EMEA, Australia, New Zealand, Japan, China, and Taiwan.
Use caution until it’s fixed
Due to catheter separation
Contact the company
What happened, in plain English
W L Gore is recalling specific Thoracic Branch Endoprosthesis Side Branch Components that may separate during use, potentially causing serious complications. This recall affects medical devices used in endovascular repair procedures. Read more at govinfonow.com/recall/49149-w-l-gore-thoracic-branch-endoprosthesis-side-branch-component-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/49149-w-l-gore-thoracic-branch-endoprosthesis-side-branch-component-recall · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2672-2026
Cite this page
“W L Gore Thoracic Branch Endoprosthesis Side Branch Component Recall: Catheter Separation.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49149-w-l-gore-thoracic-branch-endoprosthesis-side-branch-component-recall. Based on FDA recall #Z-2672-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2672-2026%22&limit=1).
Why it’s dangerous
The side branch components can separate during use, which may lead to blockages or other complications in the vascular system. This separation risk occurs during endovascular procedures where the device is used to repair aortic arch and descending thoracic aorta issues.
Who’s affected
Healthcare professionals using these medical devices for endovascular repair procedures in the US, Canada, EMEA, Australia, New Zealand, Japan, China, and Taiwan. Patients who have received these components are at risk of complications.
How to tell if you have this one
Check for catalog numbers TSB081006A, TSB081206A, TSB081506A, TSB121506A, TSB121706A, or TSB122006A in the US and Canada; TSB081006E, TSB081206E, etc. in EMEA, Australia, New Zealand; TSB081006J, TSB081206J, etc. in Japan; TSB081006W, TSB081206W, etc. in China and Taiwan.
- Brand
W L Gore- Category
Medical device
What to do — step by step
Check Device Catalog Number
Identify the catalog number on your device (e.g., TSB081006A) to confirm if it's affected.
Contact Manufacturer
Reach out to W L Gore for specific instructions on how to report or replace the device.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 39 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 50 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-2672-2026 (May 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2672-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.