{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "188210", "product_res_number": "Z-2292-2021", "event_date_initiated": "2021-05-12", "event_date_created": "2021-08-13", "recall_status": "Open, Classified", "res_event_number": "88245", "product_code": "DSY", "k_numbers": [ "K062161" ], "product_description": "Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers:\n\nHPT050010 UDI: (01)00733132606320\nHPT050010A UDI: (01)00733132606337", "code_info": "Serial Numbers for HPT050010A: 6185494PP001,\n6185494PP002,\n6185494PP004,\n6185494PP006,\n6185494PP008,\n6185494PP009,\n6185494PP010,\n6185494PP011,\n6185494PP012,\n6185495PP001,\n6185495PP002,\n6185495PP004,\n6185495PP005,\n6185495PP006,\n6185495PP007,\n6185495PP009,\n6185495PP010,\n6185495PP011,\n6185495PP012,\n6185495PP014 and \n\nSerial Numbers for HPT050010: 6185497PP001,\n6185497PP005,\n6185497PP006,\n6185497PP007,\n6185497PP008,\n6185497PP009,\n6185497PP010,\n6185497PP011,\n6185497PP012", "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": "MPD Customer Care\n800-528-8763", "reason_for_recall": "Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.", "root_cause_description": "Under Investigation by firm", "action": "On May 10, 2021, Gore issued a \"Medical Device Recall\" notification to affected customers via USPS. In addition to informing consignees about the recall, the firm asked consignees to take the following actions:\n\n1. Identify and return any unused devices within the scope of this voluntary recall.\n\n2. Please complete and sign the enclosed CUSTOMER RETURN FORM and return to\nFieldActionTeam@wlgore.com within 2 weeks of receipt of this notification.\n\n3. Please share this letter with others in your hospital or clinic as appropriate. Please\ntransfer this notice to other organization(s) as appropriate.\n\n4. Any adverse event involving the GORE PROPATEN Vascular Graft configured for\nPediatric Shunt should be reported to the manufacturer and the country specific\nregulatory authorities immediately. \n\nA. To report an event to W. L. Gore & Associates,\nemail: medcomplaints@wlgore.com, or contact:\nUSA: +1 800 528 1866 Ext. 44922 / +1 928 864 4922, Fax +1 928 864 4364\nEMEA: +49 89 4612 3440, Fax +49 89 4612 43440\nBrazil: +55 11 5502-7953, Fax: +55 11 5502-7965\n\nB. For US Customers only: Healthcare professionals and consumers may report\nadverse events or quality problems directly to FDA using the FDA MedWatch\nWebsite:https://www.accessdata.fda.gov/scripts/medwatch/index.cfm\n\n5. Please feel free to contact Gore Customer Service (email: MPDCustomerCare@wlgore.com) or Uzma Tahir, Ph.D. (928-864-3779/utahir@wlgore.com) if you have questions or concerns regarding this voluntary recall.", "distribution_pattern": "US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA\nOUS: Canada, Brazil, Europe, Saudi Arabia", "openfda": { "k_number": [ "K831865", "K933204", "K060741", "K013022", "K964625", "K221628", "K955230", "K910864", "K991602", "K983064", "K983819", "K960706", "K944858", "K020767", "K142062", "K770236", "K120006", "K102596", "K041528", "K760092", "K232312", "K811441", "K052964", "K991813", "K131778", "K760091", "K800149", "K933590", "K901682", "K822633", "K021547", "K862739", "K150389", "K964959", "K830543", "K880040", "K905269", "K870884", "K803000", "K954582", "K002007", "K000499", "K963790", "K820600", "K903964", "K941981", "K964665", "K071923", "K252445", "K060142", "K022242", "K896964", "K990800", "K130016", "K093934", "K905067", "K861808", "K092863", "K760090", "K955588", "K202703", "K141124", "K071778", "K034010", "K862697", "K992832", "K952293", "K050049", "K083169", "K090987", "K062161", "K213845", "K910863", "K162803", "K183613", "K051312", "K091778", "K922905", "K962639", "K940816", "K890597", "K130215", "K233783", "K172637", "K241070", "K894732", "K030999", "K955532", "K240083", "K010516", "K013651", "K981079", "K901641", "K854845", "K922025", "K992443", "K984182", "K770235", "K802095", "K854431", "K853101", "K904282", "K955460", "K905270", "K121532", "K032900", "K202471", "K812248", "K993667", "K162794", "K971192", "K893459", "K043552", "K091491", "K231505", "K233551", "K992960", "K871110", "K180957", "K051332", "K004011", "K093817", "K991027", "K853725", "K810376", "K914447", "K910866", "K013577", "K831880", "K933987", "K820696", "K881283", "K760130", "K961847", "K833716", "K953288", "K801621", "K970843", "K832806", "K940062", "K925123", "K040829", "K060124", "K130142", "K771819", "K203724", "K984294", "K811510", "K791828", "K884083", "K964197", "K231972", "K010517", "K912911", "K961134", "K012952", "K913143", "K990503", "K880041", "K061626", "K052282", "K910865", "K013250", "K830016", "K094044", "K821158", "K821716", "K831822", "K801156", "K124039", "K914116", "K122138", "K810845", "K903931", "K103347", "K882314", "K153523", "K880167", "K841596", "K882289", "K933943", "K001927", "K252277", "K962433", "K890182", "K983861", "K113101", "K241550" ], "pma_number": [ "P840029" ], "registration_number": [ "1721676", "3012536737", "2017233", "3010162973", "3007676031", "1721504", "1220948", "3015225571", "1640201", "3013718163", "3010407203", "1724474", "2246552", "1723241", "3006082230", "3045042524", "2020394", "3015309643", "2242352", "9612515", "1220477", "3010097171", "1720929", "1018233", "3033589330", "3008307705", "3011175548", "3006950086" ], "fei_number": [ "1721676", "3012536737", "2017233", "3007676031", "1721504", "1220948", "3015225571", "3002808437", "3013718163", "3010407203", "3003094851", "2246552", "3006082230", "3002807041", "3045042524", "2020394", "3015309643", "2242352", "1220477", "3010097171", "1000517719", "3002707083", "1720929", "1018233", "3033589330", "3008307705", "3011175548", "3006950086" ], "device_name": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3450", "device_class": "2" } } ] }