GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component
Medical device recall Z-2672-2026. Published in FDA’s Enforcement Report on Jul 8, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 8, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 41 states named
- 467 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to catheter separation
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel The GORE¿ TAG¿ Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE¿ TAG¿ Conformable Thoracic Endoprosthesis to accommodate the intended treatment site.
467 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Number / UDI-DI Code: TSB081006A (00733132654369) Serial Numbers: 31602664 Catalog Number / UDI-DI Code: TSB081006J (00733132662630) Serial Numbers: 31421864 31421865 31421870 31432339 31432340 31440637 31440638 31440639 31440640…
Every code shown here, 1,992 characters
Catalog Number / UDI-DI Code: TSB081006A (00733132654369) Serial Numbers: 31602664 Catalog Number / UDI-DI Code: TSB081006J (00733132662630) Serial Numbers: 31421864 31421865 31421870 31432339 31432340 31440637 31440638 31440639 31440640 31440641 31440642 31462061 31462062 31462063 31462064 Catalog Number / UDI-DI Code: TSB081006W (00733132650866) Serial Numbers: 31530086 Catalog Number / UDI-DI Code: TSB081206A (00733132654376) Serial Numbers: 31251480 31251481 31251482 31251484 31256961 31256963 31272521 31272522 31272523 31272525 31272526 31272527 31272528 31272529 31272530 31272531 31272533 31272534 31277206 31277207 31277208 31277209 31277210 31280248 31280249 31280250 31280251 31280252 31280254 31280255 31280256 31280257 31289924 31289925 31289926 31289928 31289929 31290547 31290548 31290549 31290550 31301117 31301118 31307814 31312365 31312366 31312367 31319612 31319613 31332034 31332036 31342363 31342364 31345617 31366643 31387545 31395549 31395550 31397877 31397878 31407669 31407670 31407674 31407675 31407676 31407677 31407678 31410726 31416877 31430425 31430426 31430428 31432234 31432235 31432236 31432239 31432240 31432241 31435513 31435514 31440731 31440734 31462230 31465437 31465438 31465440 31472456 31472457 31472459 31479940 31493741 31493742 31499222 31499223 31499226 31563552 31563560 31572876 31572880 31572882 31572891 31572892 31581245 31581253 31581254 31611436 31611437 31611441 31642687 31642688 31642689 Catalog Number / UDI-DI Code: TSB081206E (00733132640485) Serial Numbers: 31253984 31253985 31253986 31253987 31253988 31253989 31253990 31290053 31293373 31293374 Catalog Number / UDI-DI Code: TSB081206J (00733132662647) Serial Numbers: 31271809 31271810 31271811 31275136 31275137 31275138 31275139 31275140 31277767 31277768 31277769 31277770 31277771 31285319 31285320 31285321 31289881 31289882 31289883 31301127 31301128 31301129 31311216 31311217 31311218 31315622 31315623 31315624 31315625 31371534 31371535 31371536 31371537 31390397…
FDA’s list runs to 5,238 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, WA, and WI. The countries of United Arab Emirates, Australia, Austria, Canada, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Monaco, Malta, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovakia, Sweden, and Taiwan.
The states and territories these words name
41 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- New York
- Ohio
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 19, 2026.
- FDA classified it on Jul 2, 2026.
- FDA’s Enforcement Report published it on Jul 8, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- W L Gore & Associates, Inc., of Flagstaff, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,238 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.