{ "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": "149418", "product_res_number": "Z-0322-2017", "event_date_initiated": "2016-09-01", "event_date_posted": "2016-10-28", "recall_status": "Terminated", "event_date_terminated": "2017-03-27", "res_event_number": "75124", "product_code": "GAH", "product_description": "Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile.\nThe visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures", "code_info": "Lot number 151481", "firm_fei_number": "1000517638", "recalling_firm": "Medtronic Navigation, Inc.", "address_1": "826 Coal Creek Cir", "city": "Louisville", "state": "CO", "postal_code": "80027-9710", "additional_info_contact": "Tom Reimann\n720-890-3200", "reason_for_recall": "Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field.", "root_cause_description": "Mixed-up of materials/components", "action": "Medtronic sent an Urgent Medical Device Recall letter dated September 2, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their stock for the affected product and if any are found contact Medtronic to arrange for a no charge replacement. Customers were asked to complete the Customer Confirmation form attached to the letter and return it to Medtronic at RS.NavFCA@medtronic.com or by Fax to 651-367-7075. Customers with questions were instructed to contact Medtronic Technical Services at 1-800-595-9709.\nFor questions regarding this recall call 720-890-3200.", "product_quantity": "100 total units", "distribution_pattern": "Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.", "openfda": { "k_number": [ "K000932", "K972521", "K970306", "K972918", "K952737", "K110355", "K770970" ], "registration_number": [ "3009493875", "3015967359", "1220477", "3003828812", "3013666218", "1421879", "3018094310", "8044098", "3031231776", "9610612", "3012452798", "3043007473", "2030624", "9611610", "9680837", "3010673850", "3009540749", "9680619", "3042940336", "3033509898", "8040278", "9710524", "3002807314", "8010372", "3006897996", "9611827", "3004049923", "3021477808", "3033589330", "1000393132", "3009255580", "3013156185", "3015131017", "3008102049", "3011371465", "3009417901", "3014023545", "3015309643", "1836161", "3003418325", "3005809810", "3007344102", "3012536737", "3004608878", "3006460162", "8040233", "3017521423", "3007456622", "3038187464", "1646747", "3002250546", "3013540005", "2020550", "3010041511", "3010202439", "3008902714", "3014334038", "1721504", "1421101", "1923569", "3006950086", "3007125392", "2529846", "9616662", "3004215117", "3012185136", "8030607", "3014170143", "1221435", "3015212339", "3008650117", "3026297283", "8010300", "1723170", "9611112", "1835572", "3017410090", "3011137372", "3009513193", "3033536312", "3008812560", "3004371426", "8031020", "3007156625", "3025603301", "3036756245", "2518902", "3008770252", "3005596514", "3015225571", "2249529", "3015925358", "3008850074", "8010282", "1216677", "1820334", "2183449" ], "fei_number": [ "3009493875", "3015967359", "1220477", "3003828812", "3013666218", "3018094310", "3031231776", "3012452798", "3043007473", "3007290840", "3005747797", "3004028763", "3010673850", "3030600553", "3009540749", "1000517638", "3003944071", "3042940336", "3033509898", "3008133910", "3002807314", "1000136191", "3002808477", "3006897996", "3004049923", "3021477808", "3033589330", "1000393132", "3009255580", "3013156185", "3015131017", "3008102049", "3011371465", "3001452082", "3001026312", "3009417901", "3002807421", "3014023545", "3008782585", "3015309643", "3008237805", "3003418325", "3005809810", "3007344102", "3012536737", "3004608878", "3002750084", "3002807264", "3006460162", "3017521423", "3007456622", "3003499455", "3007475226", "3038187464", "1000160162", "3002250546", "3013540005", "2020550", "3010041511", "3008902714", "3014334038", "3002806315", "1721504", "1421101", "1923569", "3002786339", "3002807830", "3006950086", "3007125392", "3003249645", "3004215117", "3012185136", "3014170143", "1221435", "3015212339", "3008650117", "3026297283", "3000335778", "3004216008", "1000115048", "3009513193", "3033536312", "3008812560", "3025603301", "3003386935", "3036756245", "2518902", "3008770252", "3005596514", "3015225571", "3015925358", "3008850074", "1216677", "3006509795", "1820334", "3000206435", "2183449" ], "device_name": "Stylet, Surgical, General & Plastic Surgery", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1" } } ] }