{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 28 } }, "results": [ { "cfres_id": "215714", "product_res_number": "Z-0036-2026", "event_date_initiated": "2025-08-26", "event_date_posted": "2025-10-02", "recall_status": "Open, Classified", "res_event_number": "97474", "product_code": "DSY", "k_numbers": [ "K233551" ], "product_description": "GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.", "code_info": "REF/UDI-DI: \nECH050020J/04993024010758,\nECH050020W/00733132635450,\nECH050050J/04993024010772,\nECH050050W/00733132635474,\nECH060010A/00733132622573,\nECH060020A/00733132622597,\nECH060020J/04993024009967,\nECH060020W/00733132634729,\nECH060040/00733132605347,\nECH060040A/00733132605354,\nECH060040W/00733132619719,\nECH060050A/00733132626960,\nECH060050J/04993024009981,\nECH460045A/00733132634811,\nECH460045J/04993024010789,\nECH470045/00733132626977,\nECH470045A/00733132634811.\n\nProduct with a serial number that includes and falls within the range of 6597081PP001\nand 9853822PP024.\n\nInstructions for Use MD183888 Revision 4", "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": "928-864-3600", "reason_for_recall": "Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.", "root_cause_description": "Unknown/Undetermined by firm", "action": "On 8/26/2025, correction notices were mailed to Vascular Surgeons and other physicians who were informed of the following:\n\nNo action is required for patients who currently have the device implanted; however,\nplease be aware of delamination as a potential cause of occlusion should clinical\nissues arise in the future. Management of patients with suspected or confirmed\ndelamination should be guided by the clinical judgment of the treating physician,\nwith careful consideration of the risks and benefits of each treatment option in the\ncontext of the individual circumstance.\n\nInstructions for use will be updated to include the following:\n\nWhen performing reinterventions on the GORE ACUSEAL Vascular Graft, avoid the use of oversized balloons.\n\nA possible complication which may occur with the use of the GORE ACUSEAL Vascular Graft is delamination. Delamination may result in partial or complete occlusion due to hemodynamically significant stenosis or thrombosis and related serious harms, including additional interventions to resolve. \n\nIFUs are available at: https://eifu.goremedical.com/\n\nIn addition, customers were asked to do the following:\n1) Complete and return the acknowledgement form via email to wlgore3081@sedgwick.com\n2) This notice needs to be shared with those who should be aware within your\ninstitution or to any organization where potentially affected devices have been\ntransferred (as appropriate).\n\nTo report an event to firm, email: medcomplaints@wlgore.com\n\nQuestions can be directed to firm Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528-8763", "product_quantity": "52,306", "distribution_pattern": "US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI, NY, DC, SC, CT, NE, IA, WA, AR, NV, WV, AK, UT, ND, KS, CO, ME, MT, NM, SD, PR, WY, RI.\n\nOUS: PANAMA, CANADA, CHINA, TAIWAN, GERMANY, SLOVENIA, NORWAY, UNITED KINGDOM, ITALY, SPAIN, FINLAND, NETHERLANDS, SWEDEN, FRANCE, UNITED ARAB EMIRATES, DENMARK, PORTUGAL, AUSTRIA, SWITZERLAND, BELGIUM, TURKIYE, SLOVAK REPUBLIC, CYPRUS, SAUDI ARABIA, SOUTH AFRICA, LUXEMBOURG, FRENCH GUIANA, ANDORRA, IRELAND, NEW CALEDONIA, POLAND, ISRAEL, GREECE, GUADELOUPE, CROATIA, REUNION, BAHRAIN, HUNGARY, JAPAN", "openfda": { "k_number": [ "K172637", "K964197", "K905067", "K233551", "K941981", "K202703", "K771819", "K955532", "K914447", "K952293", "K032900", "K831822", "K830016", "K001927", "K770235", "K871110", "K800149", "K791828", "K953288", "K964625", "K034010", "K820600", "K812248", "K801156", "K071923", "K984294", "K013022", "K901682", "K810845", "K890182", "K853101", "K071778", "K131778", "K820696", "K991602", "K912911", "K992960", "K231972", "K955588", "K124039", "K830543", "K991813", "K041528", "K030999", "K121532", "K012952", "K013651", "K233783", "K021547", "K760092", "K020767", "K933590", "K880041", "K971192", "K896964", "K954582", "K090987", "K955230", "K831865", "K905269", "K991027", "K760130", "K964959", "K881283", "K122138", "K093934", "K914116", "K252277", "K203724", "K010516", "K992832", "K903964", "K905270", "K870884", "K050049", "K884083", "K060142", "K913143", "K802095", "K094044", "K854431", "K000499", "K821158", "K052964", "K052282", "K961134", "K854845", "K760091", "K150389", "K961847", "K960706", "K130215", "K013577", "K993667", "K833716", "K061626", "K183613", "K051312", "K083169", "K130142", "K894732", "K841596", "K910866", "K051332", "K091491", "K252445", "K062161", "K862739", "K180957", "K831880", "K040829", "K880167", "K811510", "K822633", "K043552", "K120006", "K113101", "K013250", "K803000", "K890597", "K955460", "K092863", "K903931", "K093817", "K944858", "K901641", "K933943", "K964665", "K861808", "K933204", "K925123", "K990800", "K241550", "K922905", "K910865", "K102596", "K010517", "K004011", "K922025", "K893459", "K162794", "K882289", "K984182", "K963790", "K241070", "K821716", "K231505", "K810376", "K970843", "K232312", "K904282", "K983861", "K933987", "K981079", "K060124", "K940062", "K983819", "K240083", "K002007", "K811441", "K103347", "K862697", "K801621", "K141124", "K990503", "K022242", "K142062", "K832806", "K202471", "K992443", "K153523", "K221628", "K962433", "K882314", "K213845", "K940816", "K091778", "K853725", "K770236", "K060741", "K910864", "K962639", "K162803", "K130016", "K760090", "K910863", "K880040", "K983064" ], "pma_number": [ "P840029" ], "registration_number": [ "3012536737", "", "2242352", "1220477", "2020394", "9612515", "3008307705", "1721676", "1723241", "1220948", "1640201", "3033589330", "1724474", "3010162973", "3007676031", "1018233", "3013718163", "3010407203", "2246552", "3015225571", "1721504", "2017233", "3010097171", "3006082230", "3011175548", "3015309643", "3006950086", "1720929" ], "fei_number": [ "3012536737", "", "2242352", "1220477", "2020394", "3008307705", "3002707083", "1721676", "1220948", "3033589330", "3007676031", "1000517719", "1018233", "3013718163", "3002807041", "3010407203", "2246552", "3015225571", "1721504", "2017233", "3010097171", "3006082230", "3011175548", "3015309643", "3006950086", "3003094851", "3002808437", "1720929" ], "device_name": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3450", "device_class": "2" } } ] }