{ "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": 1 } }, "results": [ { "cfres_id": "122925", "product_res_number": "Z-0336-2014", "event_date_initiated": "2013-10-23", "event_date_posted": "2013-11-18", "recall_status": "Terminated", "event_date_terminated": "2014-02-27", "res_event_number": "66670", "product_code": "DSY", "k_numbers": [ "K990503" ], "product_description": "Vascutek Gelsoft Vascular Graft (peripheral)\nLabeling reads in part, \"***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland***\"\n\nThe Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed, woven polyester graft indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries", "code_info": "Catalog Number 631508 Serial Numbers: 0001765391, 0001765392, 0001765393, 0001765394, 0001765395, 0001765396, 0001765397, 0001765398, 0001765399", "firm_fei_number": "1828100", "recalling_firm": "Terumo Cardiovascular Systems Corporation", "address_1": "6200 Jackson Rd", "city": "Ann Arbor", "state": "MI", "postal_code": "48103-9586", "additional_info_contact": "734-741-6173", "reason_for_recall": "Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled.", "root_cause_description": "Error in labeling", "action": "Terumo CVS called affected consignees (via telephone)on 10/23/2013 of this device removal. Terumo CVS advised users to discontinue use and return all affected grafts in inventory. Terumo will replace or issue credit for returned grafts. Terumo provided consignees with the reason of the removal, potential hazard, and description of affected product. Terumo addressed any questions from the consignees. Consignees with questions were instructed to contact Terumo CVS Customer Service at 800-521-2818.\nFor questions regarding this recall call 734-741-6173.", "product_quantity": "9", "distribution_pattern": "US Distribution in the states of: NC and CA.", "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" } } ] }