{ "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": 1 } }, "results": [ { "cfres_id": "193674", "product_res_number": "Z-1261-2022", "event_date_initiated": "2022-04-27", "event_date_created": "2022-06-13", "recall_status": "Open, Classified", "res_event_number": "90178", "product_code": "HCG", "k_numbers": [ "K203432" ], "product_description": "AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX;\n\nAxium Detachable Coil System REF QC-10-30-3D;", "code_info": "Product Number: QC-4-12-HELIX UDI-DI (GTIN) Code: 00847536029590 Lot Number: B240079  Product Number: QC-10-30-3D UDI-DI (GTIN) Code: 00847536030138 Lot Number: B240084", "firm_fei_number": "3004904811", "recalling_firm": "Micro Therapeutics, Inc.", "address_1": "9775 Toledo Way", "city": "Irvine", "state": "CA", "postal_code": "92618-1811", "reason_for_recall": "Due to incorrect size and configuration labeling of the detachable coil system.", "root_cause_description": "Labeling Change Control", "action": "On 04/27/2022, Medtronic initiated distribution of a retrieval notice via mail courier service to impacted OUS Consignees (hospital accounts) informing them that Medtronic has received reports that the incorrect size of Axium Detachable Coil System were found in device packages and has identified that two (2) production lots have been incorrectly labelled.\n\nCustomers are asked to immediately take the following actions:\n1.\tDo NOT use any impacted product. Remove and quarantine all unused impacted products in your inventory. \n\n2.\tReturn the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product as necessary. If alternative product is needed, your Medtronic representative can assist you with identifying suitable replacement product.\n \n3.\tComplete and return the Customer Confirmation Form enclosed in this letter acknowledging that you have received this information. \n\nQuestions should be addressed to Medtronic representatives or email the Office of Medical Affairs at rs.nvoma@medtronic.com.", "product_quantity": "96 systems", "distribution_pattern": "International distribution in the countries of China and Republic of Korea.", "openfda": { "k_number": [ "K153658", "K151572", "K132952", "K242582", "K090168", "K042297", "K991549", "K031578", "K920324", "K071962", "K900723", "K001678", "K093358", "K210638", "K071634", "K965174", "K022735", "K162704", "K070707", "K040694", "K112385", "K082461", "K925523", "K233420", "K203625", "K063254", "K141134", "K082324", "K123338", "K050954", "K022427", "K032542", "K041649", "K964367", "K042539", "K170852", "K050543", "K153594", "K032553", "K092666", "K080666", "K222533", "K103758", "K120908", "K151447", "K192068", "K960705", "K080967", "K151760", "K090357", "K113822", "K901337", "K951256", "K070656", "K132317", "K944354", "K012145", "K093973", "K010026", "K180653", "K093142", "K252694", "K063653", "K120330", "K254221", "K032619", "K142429", "K120686", "K103008", "K082739", "K200030", "K060625", "K173614", "K913312", "K032707", "K052509", "K080379", "K911779", "K022420", "K160832", "K012985", "K053197", "K123560", "K120274", "K212455", "K120850", "K090001", "K113457", "K140104", "K094018", "K113412", "K143218", "K071246", "K102672", "K993415", "K083646", "K171747", "K161429", "K002056", "K014041", "K993417", "K090891", "K050700", "K925876", "K203432", "K260351", "K913556", "K142513", "K161367", "K914866", "K030475", "K112226", "K983483", "K033761", "K021914", "K023089", "K223386", "K033836", "K891688", "K041551", "K060747", "K150319", "K220040", "K162999", "K192955", "K993418", "K261772", "K031168", "K123377", "K002181", "K051425", "K072173", "K091641", "K132482", "K160096", "K232955", "K093919", "K053160", "K131475", "K131948", "K103305", "K963307", "K030963", "K020434", "K972881", "K033372", "K073442", "K173711", "K001083", "K951314", "K031852", "K062036", "K171862", "K962503", "K964021", "K961923", "K252700", "K000651", "K053548", "K103355", "K042231", "K211344", "K033813", "K080437", "K021494", "K242243", "K031049", "K112181", "K032872", "K901721", "K133310", "K111451", "K242154", "K100454", "K172390", "K991139", "K871047", "K032497", "K020033", "K251832", "K073419", "K262419", "K161452", "K032590", "K051560", "K030392", "K230284" ], "registration_number": [ "9616684", "3008114965", "3008853977", "3031550970", "", "9617601", "1721676", "3015531723", "3027595249", "3044156918", "9614654", "3012536737", "3005168196", "3002807295", "3016245399", "1226348", "3007628272", "3012543881", "3008824097", "3013556777", "3017961114", "3010178296", "3010173425", "3010079067", "2126666", "3008264254", "3015309643", "3000143502", "3014162263", "3013944123", "1820334", "2133641", "3015550451", "3008881809", "3006950086", "1220477", "3015453963", "2134265", "3043869342", "2032364", "9615728", "2022435", "3014644549", "2124215", "2029214", "1043729", "3016591327", "3015615738", "3016540856", "3007029079", "3007738736", "3013353964", "2011171", "3013758550", "3009380063", "3008837339", "3033589330", "3003524171", "3016609702", "3008307705", "2030598", "3012931345", "1225687", "2029275", "3009761573" ], "fei_number": [ "", "3008114965", "3008853977", "3031550970", "1000518731", "3044156918", "1721676", "3015531723", "3027595249", "3012536737", "3005168196", "3002534070", "3002807295", "3002808904", "3016245399", "3007628272", "3012543881", "3008824097", "3013556777", "3017961114", "3002095335", "3002808761", "3010079067", "3002807036", "3000203466", "3001451463", "2126666", "3008264254", "3015309643", "3000143502", "3014162263", "3013944123", "1820334", "3015550451", "3008881809", "1220477", "1000220862", "1000306431", "3015453963", "3043869342", "3003323921", "2022435", "3014644549", "2124215", "1043729", "3003110073", "3015615738", "3016591327", "3016540856", "3007738736", "3007029079", "3013353964", "3002947440", "2011171", "3013758550", "3002913962", "3009380063", "3008837339", "3033589330", "3003524171", "3016609702", "3008307705", "3012931345", "3006950086", "3009761573" ], "device_name": "Device, Neurovascular Embolization", "medical_specialty_description": "Neurology", "regulation_number": "882.5950", "device_class": "2" } } ] }