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RecallWatchMedical Device Safety
Class IIOngoingZ-2672-2026

W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…

W L Gore & Associates, Inc.Flagstaff, AZ, United StatesReported Jul 8, 2026 · 10 days ago
Legal News Analyst ·

Reason for recall

Due to catheter separation

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI CodeCatalog # Number
    400 affected lots
    31602664TSB081006J314218643142186531421870314323393143234031440637
    +392 more314406383144063931440640314406413144064231462061314620623146206331462064TSB081006W31530086TSB081206A312514803125148131251482312514843125696131256963312725213127252231272523312725253127252631272527312725283127252931272530312725313127253331272534312772063127720731277208312772093127721031280248312802493128025031280251312802523128025431280255312802563128025731289924312899253128992631289928312899293129054731290548312905493129055031301117313011183130781431312365313123663131236731319612313196133133203431332036313423633134236431345617313666433138754531395549313955503139787731397878314076693140767031407674314076753140767631407677314076783141072631416877314304253143042631430428314322343143223531432236314322393143224031432241314355133143551431440731314407343146223031465437314654383146544031472456314724573147245931479940314937413149374231499222314992233149922631563552315635603157287631572880315728823157289131572892315812453158125331581254316114363161143731611441316426873164268831642689TSB081206E31253984312539853125398631253987312539883125398931253990312900533129337331293374TSB081206J312718093127181031271811312751363127513731275138312751393127514031277767312777683127776931277770312777713128531931285320312853213128988131289882312898833130112731301128313011293131121631311217313112183131562231315623313156243131562531371534313715353137153631371537313903973139039831390399313975683139756931397570314118613141186231411863314118643141186531411866314218713142187231421873314218743142187531421876314218773142187831421879314218803143874631438747314387483143874931438750314406433144064431440645314532483145324931453250314532513146206531462066314620673146206831472889314728903147458131474582314821663148216731571943315719443157194531571946315719473158209531582096TSB081206W3124944031249441312494423125613231256133312561343125613531256136312561373125613831256139312561403125614131258012312580133125801431258015312580163126680431266805312668063127772531277726312777273127772831277729312762363127623731276238312762393127624031276241312850663128506731285068312897573128975831289759312897603128976131293955312939563129395731293958312939593129396031293961312939623129396331293964313659083140858031408581TSB081506A31272538312725403127254231272543312725443127254531272546312725473127254831272549312725523127255331268417312684183126842331268426312802823128028431280285312802903128029131280292312802933128029531289931312899323128993431289935312996963129969731299699313093653130936631312893313128943131289531312896313196193131962031319624313196253132503431325036313250373133204831332049313320503133537731335378313353793133538031335381313353823133538331335385313632323136323631366645313666463138873231388734314010683140106931401070314255033142550431425505314255063142550731425509314255103142551131430434314304353143552031435524313423673134562131345623313456243145613331456134314622363148444131484442314844463148444831493794314937953149379731499229314992303149923131499234314992383150669831506699315067003151060131510606315955563159555731595562316026703160267531607624316165083162272031622721TSB081506W31274125312741263127412731319417313194183131941931367372TSB121506A

What the firm is doing

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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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