{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191705", "product_res_number": "Z-0695-2022", "event_date_initiated": "2022-02-04", "event_date_posted": "2022-03-07", "recall_status": "Terminated", "event_date_terminated": "2024-10-02", "res_event_number": "89470", "product_code": "MCW", "k_numbers": [ "K212027" ], "product_description": "Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.", "code_info": "GTIN 00763000402419", "firm_fei_number": "2183870", "recalling_firm": "ev3 Inc.", "address_1": "4600 Nathan Ln N", "city": "Plymouth", "state": "MN", "postal_code": "55442-2890", "additional_info_contact": "Medtronic Customer Service\n800-854-3570", "reason_for_recall": "The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.", "root_cause_description": "Labeling design", "action": "The recalling firm began issuing the URGENT MEDICAL DEVICE NOTICE dated February 2022 on 2/4/2022 via 2-day UPS delivery. The letter explained the issue and instructed the consignee to adhere to the existing IFU instructions and warnings and precautions listed in the letter to reduce the risk of guidewire prolapse. The Customer Instructions included the notice was to be shared with all who needed to be aware within the consignee's organization or to any other organization where the product has been transferred; to review the IFU included with the product prior to use, noting the warnings and precautions listed in the notice; and to complete the Customer Confirmation Form to acknowledge receipt of the notice and that the appropriate action has been taken. It was to be emailed to the recalling firm.", "product_quantity": "245 devices", "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.", "openfda": { "k_number": [ "K060904", "K133023", "K250385", "K970233", "K982657", "K132682", "K030504", "K053460", "K901206", "K230005", "K071432", "K181877", "K233483", "K152181", "K242757", "K993648", "K241553", "K161361", "K982363", "K173862", "K942457", "K180416", "K121774", "K222837", "K170792", "K231538", "K093456", "K182397", "K954205", "K960379", "K061063", "K152275", "K082186", "K083837", "K091029", "K935929", "K111723", "K260244", "K973669", "K133999", "K082981", "K220109", "K170059", "K220962", "K970080", "K033793", "K162326", "K043553", "K072195", "K250723", "K904680", "K133399", "K141801", "K140775", "K120242", "K133566", "K182972", "K172236", "K181642", "K160827", "K003570", "K100462", "K123632", "K990829", "K230709", "K172687", "K150732", "K953997", "K162561", "K140944", "K170191", "K151145", "K081944", "K092332", "K913450", "K212047", "K143328", "K072748", "K031610", "K202835", "K971984", "K993564", "K103618", "K041630", "K172386", "K233668", "K110626", "K153460", "K083489", "K061188", "K211518", "K094036", "K915238", "K093301", "K033997", "K954604", "K163264", "K220568", "K111388", "K122987", "K203008", "K993816", "K110389", "K120346", "K182341", "K093918", "K210586", "K220116", "K131092", "K970296", "K111229", "K082664", "K071427", "K963925", "K180694", "K172315", "K090521", "K060016", "K090325", "K081328", "K242947", "K152694", "K922970", "K190634", "K191419", "K920707", "K072800", "K221077", "K212351", "K933238", "K071350", "K091509", "K013473", "K151260", "K101221", "K022640", "K212027", "K040252", "K924712", "K960970", "K021096", "K101334", "K211738", "K122916", "K024243", "K130637" ], "registration_number": [ "2011171", "3012669557", "3000279201", "2024311", "1000121056", "1225687", "2648045", "3016257349", "3020968442", "3008814558", "1643817", "3008439199", "3000126629", "3007048256", "9616684", "2124215", "3032916632", "3003708554", "3007284006", "3009756153", "3007695959", "1721676", "2244478", "2183744", "3004091615", "3014443747", "3015124694", "3006946276", "3010173425", "3016445722", "3002631703", "3017896194", "3004859241", "3004742232", "3006702495", "3010273872", "2020394", "3008363989", "3002807314", "3010041511", "1724474", "3010280625", "3003780911", "3011137372", "1061124", "2939520", "2134265", "3014254831", "3003862657", "1625425", "2183870", "9612164" ], "fei_number": [ "2011171", "3012669557", "3005747797", "3000279201", "1000121056", "2024311", "2648045", "3016257349", "3020968442", "3008814558", "3001451463", "3008439199", "1643817", "3000126629", "3007048256", "1000136269", "2124215", "3032916632", "3002095335", "3003708554", "3002913962", "3007284006", "3009756153", "3007695959", "1721676", "3003094851", "2183744", "3004091615", "3014443747", "3015124694", "3006946276", "3016445722", "3002631703", "1000512168", "3004859241", "3004742232", "3017896194", "3006702495", "3010273872", "2020394", "3002806434", "3008363989", "3002807314", "3010041511", "3010280625", "3003780911", "3002807036", "2939520", "3014254831", "3003862657", "1625425", "2183870" ], "device_name": "Catheter, Peripheral, Atherectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4875", "device_class": "2" } } ] }