{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183677", "product_res_number": "Z-0290-2021", "event_date_initiated": "2020-09-09", "event_date_created": "2020-10-23", "recall_status": "Open, Classified", "res_event_number": "86420", "product_code": "MIH", "pma_numbers": [ "P040043" ], "product_description": "GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System", "code_info": "CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X* TGM282820X* TGM313110X* TGM313115X* TGM313120X* TGM343410X* TGM343415X* TGM343420X* TGM373710X* TGM373715X* TGM373720X* TGM404010X* TGM404015X* TGM404020X* TGM454510X* TGM454515X* TGM454520X* TGM262110X* TGM312610X* TGMR313110X* TGMR313115X* TGMR313120X* TGMR312610X* TGMR373710X* TGMR373715X* TGMR373720X* TGMR404010X* TGMR404015X* TGMR404020X* *X is a placeholder for enumeration code: E=EMEA, Australia, New Zealand; J=Japan  All lot numbers", "firm_fei_number": "2017233", "recalling_firm": "W L Gore & Associates, Inc.", "address_1": "3750 W Kiltie Ln", "city": "Flagstaff", "state": "AZ", "postal_code": "86005-8712", "additional_info_contact": "800-528-8763", "reason_for_recall": "Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible", "root_cause_description": "Unknown/Undetermined by firm", "action": "On 09/23/2020, the firm sent an \"URGENT Medical Device Safety Correction\" via First Class Postal (USPS) informing them that all lots of its Thoracic Stent Graft Systems may encounter inability to complete secondary deployment and that the Recalling Firm will be updating it Instruction for Use to include a new Warning:\nSecondary deployment events have occurred where the device does not open\nto full diameter after Secondary Deployment Handle actuation, and the\ndeployment line is not accessible via the Deployment Line Access Hatch. If this\nevent occurs, Gore recommends using the GORE Tri-Lobe Balloon Catheter to\nexpand the device from trailing end to leading end after complete delivery\nsystem component removal. (Please refer to the GORE Tri-Lobe Balloon\nCatheter Instructions for Use for pertinent recommended volume, directions\nand warnings.) Ballooning of a non-fully expanded stent graft may lead to\nimproper placement of the stent graft and/or branch vessel occlusion or\nobstruction. Use of an occlusion balloon may lead to device distal displacement\nduring deployment (windsock effect) and has been observed to lead to branch\nvessel occlusion or obstruction.\n\nCustomers are instructed to:\n-Take note of amendment/reinforcement of Instructions For Use (IFU)\n- Please respond to the enclosed acknowledgement\n- Please share this letter with others in your hospital or clinic as appropriate\nThe Recalling Firm is providing physicians with this information so that appropriate risk-related decisions can be made with the patient when considering the Thoracic Stent Graft System. The Recalling Firm maintains its confidence in the safety and efficacy of the device and is not removing the affected products from the market.\nThere are no actions required for patients already implanted with the Thoracic Stent Graft.\n\nPlease contact the Recalling Firm's Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528-8763) with any\nquestions related to this", "product_quantity": "13860 units", "distribution_pattern": "U.S. - Nationwide\n\nO.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom", "openfda": { "pma_number": [ "P040043", "P210032", "P070027", "P100040", "P040002", "P120006", "P140016", "P020004", "P190015", "P110038", "P990020", "P100021", "P150002", "P180001", "P990017", "P200030", "P020018", "P070016", "P200045", "P110032", "P070007" ], "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "3004497303", "2011171", "1054811", "3012102437", "1721686", "2017233", "3016521833", "3005562917", "9710641", "3002808486", "1219313", "9617601", "2247858", "3005580113", "3003678543", "9616099", "3009526575", "2953200", "1721676", "3006131984", "3007738736", "3013164176", "3008307705", "9680271", "2030624", "3002807314", "3008011247", "3009380063", "3011324393", "3007284313", "1820334", "9680654", "3011063223", "9612164" ], "fei_number": [ "3003259710", "3004497303", "2011171", "3003565456", "3012102437", "1721686", "2017233", "3016521833", "3005562917", "3002808486", "1000114185", "1219313", "3003528016", "3005580113", "3003678543", "3002534070", "3009526575", "1721676", "3006131984", "3007738736", "3013164176", "3002806434", "3008307705", "3000206435", "3002807314", "3008011247", "3009380063", "3011324393", "3001452571", "1000135961", "3007530363", "1820334", "3007284313", "3011063223" ] } } ] }