{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220934", "product_res_number": "Z-2672-2026", "event_date_initiated": "2026-05-19", "event_date_posted": "2026-07-02", "recall_status": "Open, Classified", "res_event_number": "99140", "product_code": "MIH", "pma_numbers": [ "P210032" ], "product_description": "GORE TAG Thoracic Branch Endoprosthesis Side Branch Component\nCatalog Numbers (by Region)\nUnited States (includes Puerto Rico) and Canada:\nTSB080806A, TSB081006A, TSB081206A,\nTSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A\nEMEA Countries, Australia, New Zealand:\nTSB080806E, TSB081006E, TSB081206E,\nTSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E\nJapan:\nTSB080806J, TSB081006J, TSB081206J,\nTSB081506J, TSB081706J, TSB121506J,\nTSB121706J, TSB122006J\nChina and Taiwan:\nTSB080806W, TSB081006W, TSB081206W,\nTSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W\n\nThe 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\nThe 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_info": "Catalog Number / UDI-DI Code:\nTSB081006A (00733132654369)\nSerial Numbers:\n31602664\n\nCatalog Number / UDI-DI Code:\nTSB081006J (00733132662630)\nSerial Numbers:\n31421864\n31421865\n31421870\n31432339\n31432340\n31440637\n31440638\n31440639\n31440640\n31440641\n31440642\n31462061\n31462062\n31462063\n31462064\n\nCatalog Number / UDI-DI Code:\nTSB081006W (00733132650866)\nSerial Numbers:\n31530086\n\nCatalog Number / UDI-DI Code:\nTSB081206A (00733132654376)\nSerial Numbers:\n31251480\n31251481\n31251482\n31251484\n31256961\n31256963\n31272521\n31272522\n31272523\n31272525\n31272526\n31272527\n31272528\n31272529\n31272530\n31272531\n31272533\n31272534\n31277206\n31277207\n31277208\n31277209\n31277210\n31280248\n31280249\n31280250\n31280251\n31280252\n31280254\n31280255\n31280256\n31280257\n31289924\n31289925\n31289926\n31289928\n31289929\n31290547\n31290548\n31290549\n31290550\n31301117\n31301118\n31307814\n31312365\n31312366\n31312367\n31319612\n31319613\n31332034\n31332036\n31342363\n31342364\n31345617\n31366643\n31387545\n31395549\n31395550\n31397877\n31397878\n31407669\n31407670\n31407674\n31407675\n31407676\n31407677\n31407678\n31410726\n31416877\n31430425\n31430426\n31430428\n31432234\n31432235\n31432236\n31432239\n31432240\n31432241\n31435513\n31435514\n31440731\n31440734\n31462230\n31465437\n31465438\n31465440\n31472456\n31472457\n31472459\n31479940\n31493741\n31493742\n31499222\n31499223\n31499226\n31563552\n31563560\n31572876\n31572880\n31572882\n31572891\n31572892\n31581245\n31581253\n31581254\n31611436\n31611437\n31611441\n31642687\n31642688\n31642689\n\nCatalog Number / UDI-DI Code:\nTSB081206E (00733132640485)\nSerial Numbers:\n31253984\n31253985\n31253986\n31253987\n31253988\n31253989\n31253990\n31290053\n31293373\n31293374\n\nCatalog Number / UDI-DI Code:\nTSB081206J (00733132662647)\nSerial Numbers:\n31271809\n31271810\n31271811\n31275136\n31275137\n31275138\n31275139\n31275140\n31277767\n31277768\n31277769\n31277770\n31277771\n31285319\n31285320\n31285321\n31289881\n31289882\n31289883\n31301127\n31301128\n31301129\n31311216\n31311217\n31311218\n31315622\n31315623\n31315624\n31315625\n31371534\n31371535\n31371536\n31371537\n31390397\n31390398\n31390399\n31397568\n31397569\n31397570\n31411861\n31411862\n31411863\n31411864\n31411865\n31411866\n31421871\n31421872\n31421873\n31421874\n31421875\n31421876\n31421877\n31421878\n31421879\n31421880\n31438746\n31438747\n31438748\n31438749\n31438750\n31440643\n31440644\n31440645\n31453248\n31453249\n31453250\n31453251\n31462065\n31462066\n31462067\n31462068\n31472889\n31472890\n31474581\n31474582\n31482166\n31482167\n31571943\n31571944\n31571945\n31571946\n31571947\n31582095\n31582096\n\nCatalog Number / UDI-DI Code:\nTSB081206W (00733132650873)\nSerial Numbers:\n31249440\n31249441\n31249442\n31256132\n31256133\n31256134\n31256135\n31256136\n31256137\n31256138\n31256139\n31256140\n31256141\n31258012\n31258013\n31258014\n31258015\n31258016\n31266804\n31266805\n31266806\n31277725\n31277726\n31277727\n31277728\n31277729\n31276236\n31276237\n31276238\n31276239\n31276240\n31276241\n31285066\n31285067\n31285068\n31289757\n31289758\n31289759\n31289760\n31289761\n31293955\n31293956\n31293957\n31293958\n31293959\n31293960\n31293961\n31293962\n31293963\n31293964\n31365908\n31408580\n31408581\n\nCatalog Number / UDI-DI Code:\nTSB081506A (00733132654383)\nSerial Numbers:\n31272538\n31272540\n31272542\n31272543\n31272544\n31272545\n31272546\n31272547\n31272548\n31272549\n31272552\n31272553\n31268417\n31268418\n31268423\n31268426\n31280282\n31280284\n31280285\n31280290\n31280291\n31280292\n31280293\n31280295\n31289931\n31289932\n31289934\n31289935\n31299696\n31299697\n31299699\n31309365\n31309366\n31312893\n31312894\n31312895\n31312896\n31319619\n31319620\n31319624\n31319625\n31325034\n31325036\n31325037\n31332048\n31332049\n31332050\n31335377\n31335378\n31335379\n31335380\n31335381\n31335382\n31335383\n31335385\n31363232\n31363236\n31366645\n31366646\n31388732\n31388734\n31401068\n31401069\n31401070\n31425503\n31425504\n31425505\n31425506\n31425507\n31425509\n31425510\n31425511\n31430434\n31430435\n31435520\n31435524\n31342367\n31345621\n31345623\n31345624\n31456133\n31456134\n31462236\n31484441\n31484442\n31484446\n31484448\n31493794\n31493795\n31493797\n31499229\n31499230\n31499231\n31499234\n31499238\n31506698\n31506699\n31506700\n31510601\n31510606\n31595556\n31595557\n31595562\n31602670\n31602675\n31607624\n31616508\n31622720\n31622721\n\nCatalog Number / UDI-DI Code:\nTSB081506W (00733132644414)\nSerial Numbers:\n31274125\n31274126\n31274127\n31319417\n31319418\n31319419\n31367372\n\nCatalog Number / UDI-DI Code:\nTSB121506A (00733132654406)\nSerial Numbers:\n31320042\n31320043\n31320044\n31332059\n31332060\n31342369\n31342371\n31412313\n31412314\n31412316\n31412317\n31412320\n31416880\n31416881\n31416882\n31416883\n31416885\n31420186\n31420187\n31420188\n31420189\n31420190\n31445434\n31445435\n31445437\n31445438\n31462238\n31462239\n31462241\n31465442\n31465446\n31472477\n31472478\n31484427\n31484429\n31484431\n31484432\n31484433\n31493782\n31493783\n31506692\n31506693\n31506695\n31534695\n31534698\n31534699\n31536819\n31586919\n31586921\n31586922\n31586925\n31586928\n\nCatalog Number / UDI-DI Code:\nTSB121506W (00733132650897)\nSerial Numbers:\n31380152\n\nCatalog Number / UDI-DI Code:\nTSB121706A (00733132654413)\nSerial Numbers:\n31541449\n\nCatalog Number / UDI-DI Code:\nTSB122006A (00733132654420)\nSerial Numbers:\n31299708\n31299710\n31299711\n31309386\n31326055\n31326057\n31534182\n31534183\n31534185\n31552406\n31552407\n31591151\n31595551\n31595552\n31595553\n\nCatalog Number / UDI-DI Code:\nTSB122006E (00733132640539)\nSerial Numbers:\n31298916\n31298917\n31311743\n31320146\n31405481\n31405482\n31405483", "firm_fei_number": "2017233", "recalling_firm": "W L Gore & Associates, Inc.", "address_1": "1505 N 4th St", "city": "Flagstaff", "state": "AZ", "postal_code": "86004-5867", "additional_info_contact": "MPDCustomerCare\n800-528-8763", "reason_for_recall": "Due to catheter separation", "root_cause_description": "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.\n\nCustomers are being reminded of pertinent Instructions for Use and Warnings and Considerations.\n-Per the IFU - Gore recommends use of a through-and-through side branch wire where clinically and anatomically feasible.\n-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. \n-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. \n-Complete and sign the \"RETURN ACKOWLEDGEMENT FORM\" and return to FieldActionTeam@wlgore.com and share notice with those within their institution \n\nFor Questions - contact me, Gore Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528-8763), or your local Field Sales Associate.", "product_quantity": "467 devices", "distribution_pattern": "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.", "openfda": { "pma_number": [ "P070027", "P990020", "P110038", "P120006", "P100021", "P070007", "P070016", "P200030", "P210032", "P040043", "P110032", "P990017", "P020018", "P040002", "P200045", "P100040", "P150002", "P140016", "P020004", "P190015", "P180001" ], "registration_number": [ "2030624", "9612164", "3009526575", "3009380063", "3008011247", "3013164176", "3008307705", "3012102437", "9617601", "1820334", "3006131984", "3004497303", "9680654", "9616099", "3007284313", "2953200", "1219313", "3011063223", "3002807314", "3011324393", "3002808486", "2017233", "1721676", "1721686", "3016521833", "9710641", "3003678543", "3007738736", "3005580113", "3005562917", "2247858", "2011171", "9680271", "1054811" ], "fei_number": [ "1000114185", "3002806434", "3000206435", "3009526575", "3009380063", "3008011247", "3013164176", "3008307705", "3012102437", "3001452571", "1820334", "3003565456", "3006131984", "3004497303", "3007284313", "1219313", "3011063223", "3002807314", "3011324393", "3002808486", "2017233", "1721676", "1721686", "3016521833", "3003678543", "3003259710", "3007738736", "3003528016", "3005580113", "1000135961", "3002534070", "3005562917", "3007530363", "2011171" ], "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }