Class 2 Device Recall GORE TAG Thoracic Branch Endoprosthesis Side Branch Component

• Date Initiated by Firm: May 19, 2026
• Date Posted: July 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2672-2026
• Recall Event ID: 99140
• PMA Number: P210032
• Product Classification: System, endovascular graft, aortic aneurysm treatment - Product Code MIH
• Product: 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.
• Code Information: 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 31390398 31390399 31397568 31397569 31397570 31411861 31411862 31411863 31411864 31411865 31411866 31421871 31421872 31421873 31421874 31421875 31421876 31421877 31421878 31421879 31421880 31438746 31438747 31438748 31438749 31438750 31440643 31440644 31440645 31453248 31453249 31453250 31453251 31462065 31462066 31462067 31462068 31472889 31472890 31474581 31474582 31482166 31482167 31571943 31571944 31571945 31571946 31571947 31582095 31582096 Catalog Number / UDI-DI Code: TSB081206W (00733132650873) Serial Numbers: 31249440 31249441 31249442 31256132 31256133 31256134 31256135 31256136 31256137 31256138 31256139 31256140 31256141 31258012 31258013 31258014 31258015 31258016 31266804 31266805 31266806 31277725 31277726 31277727 31277728 31277729 31276236 31276237 31276238 31276239 31276240 31276241 31285066 31285067 31285068 31289757 31289758 31289759 31289760 31289761 31293955 31293956 31293957 31293958 31293959 31293960 31293961 31293962 31293963 31293964 31365908 31408580 31408581 Catalog Number / UDI-DI Code: TSB081506A (00733132654383) Serial Numbers: 31272538 31272540 31272542 31272543 31272544 31272545 31272546 31272547 31272548 31272549 31272552 31272553 31268417 31268418 31268423 31268426 31280282 31280284 31280285 31280290 31280291 31280292 31280293 31280295 31289931 31289932 31289934 31289935 31299696 31299697 31299699 31309365 31309366 31312893 31312894 31312895 31312896 31319619 31319620 31319624 31319625 31325034 31325036 31325037 31332048 31332049 31332050 31335377 31335378 31335379 31335380 31335381 31335382 31335383 31335385 31363232 31363236 31366645 31366646 31388732 31388734 31401068 31401069 31401070 31425503 31425504 31425505 31425506 31425507 31425509 31425510 31425511 31430434 31430435 31435520 31435524 31342367 31345621 31345623 31345624 31456133 31456134 31462236 31484441 31484442 31484446 31484448 31493794 31493795 31493797 31499229 31499230 31499231 31499234 31499238 31506698 31506699 31506700 31510601 31510606 31595556 31595557 31595562 31602670 31602675 31607624 31616508 31622720 31622721 Catalog Number / UDI-DI Code: TSB081506W (00733132644414) Serial Numbers: 31274125 31274126 31274127 31319417 31319418 31319419 31367372 Catalog Number / UDI-DI Code: TSB121506A (00733132654406) Serial Numbers: 31320042 31320043 31320044 31332059 31332060 31342369 31342371 31412313 31412314 31412316 31412317 31412320 31416880 31416881 31416882 31416883 31416885 31420186 31420187 31420188 31420189 31420190 31445434 31445435 31445437 31445438 31462238 31462239 31462241 31465442 31465446 31472477 31472478 31484427 31484429 31484431 31484432 31484433 31493782 31493783 31506692 31506693 31506695 31534695 31534698 31534699 31536819 31586919 31586921 31586922 31586925 31586928 Catalog Number / UDI-DI Code: TSB121506W (00733132650897) Serial Numbers: 31380152 Catalog Number / UDI-DI Code: TSB121706A (00733132654413) Serial Numbers: 31541449 Catalog Number / UDI-DI Code: TSB122006A (00733132654420) Serial Numbers: 31299708 31299710 31299711 31309386 31326055 31326057 31534182 31534183 31534185 31552406 31552407 31591151 31595551 31595552 31595553 Catalog Number / UDI-DI Code: TSB122006E (00733132640539) Serial Numbers: 31298916 31298917 31311743 31320146 31405481 31405482 31405483
• FEI Number: 2017233
• Recalling Firm/ Manufacturer: W L Gore & Associates, Inc.; 1505 N 4th St; Flagstaff AZ 86004-5867
• For Additional Information Contact: MPDCustomerCare; 800-528-8763
• Manufacturer Reason for Recall: Due to catheter separation
• FDA Determined Cause: Under Investigation by firm
• Action: On 05/21/2026, the firm thru a third-party (Sedgwick) sent via certified mail an "URGENT Medical Device Safety Correction/Field Safety Notice" informing customer that Gore received 5 reports involving catheter separation of the GORE TAG Thoracic Branch Endoprosthesis (TBE) Side Branch (SB) Component during clinical use. In all cases, the failure occurred at the interface between the main catheter shaft and an over molded transition near where the trailing end of the device is positioned on the catheter. Customers are being reminded of pertinent Instructions for Use and Warnings and Considerations. -Per the IFU - Gore recommends use of a through-and-through side branch wire where clinically and anatomically feasible. -rotation of the SB delivery catheter is cautioned against: Caution: Do not rotate the SB Component delivery catheter. Catheter breakage or inadvertent deployment has occurred. -Caution: Do not continue advancement or retraction of the & delivery catheter if resistance is felt. Stop and assess the cause of resistance. Vessel, endoprosthesis, or delivery catheter damage may occur. -Complete and sign the "RETURN ACKOWLEDGEMENT FORM" and return to FieldActionTeam@wlgore.com and share notice with those within their institution For Questions - contact me, Gore Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528-8763), or your local Field Sales Associate.
• Quantity in Commerce: 467 devices
• 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MIH