{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "160822", "product_res_number": "Z-0505-2018", "event_date_initiated": "2017-09-14", "event_date_created": "2018-10-11", "recall_status": "Terminated", "event_date_terminated": "2019-11-04", "res_event_number": "78897", "product_code": "MCW", "k_numbers": [ "K152694" ], "product_description": "Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.", "code_info": "Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145", "firm_fei_number": "3004742232", "recalling_firm": "Cardiovascular Systems Inc", "address_1": "1225 Old Highway 8 NW", "city": "Saint Paul", "state": "MN", "postal_code": "55112-6416", "additional_info_contact": "Field Action Hotline\n651-259-2800", "reason_for_recall": "Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.", "root_cause_description": "Labeling mix-ups", "action": "On 09/14/2017 the firm sent letters to their consignees explaining the recall and given the following instructions:\nPlease immediately remove from use and return the affected Product Name devices to CSI. To do so:\n1) Complete the attached Customer Acknowledgement Form\na. Per lot, document the quantity of all devices that are to be returned.\nb. Per lot, document the quantity of all devices that have been consumed.\n2) Place the Acknowledgement Form with the device\n3) Return the device and Acknowledgement Form to CSI using the pre-paid FedEx label\na. If you would like, a CSI Sales Representative can return the device and form. Please contact the CSI Recall Coordinator to organize pick up and return of the product. If all products specified in this recall notice have previously been consumed, used or are no longer available for return to CSI, please complete the Customer Acknowledgment Form per the above, and return the form to CSI in the provided FedEx envelope.\n\nContact Information: csifieldactionhotline@csi360.com\n651-259-2800 - Tel", "product_quantity": "8", "distribution_pattern": "FL, IL, MI, MN, MO, NY, SC, TX, and WI", "openfda": { "k_number": [ "K971984", "K143328", "K100462", "K172315", "K053460", "K191419", "K212047", "K013473", "K203008", "K954205", "K151145", "K061188", "K942457", "K954604", "K170792", "K133399", "K132682", "K170059", "K963925", "K092332", "K162326", "K111229", "K122916", "K071427", "K231538", "K915238", "K093301", "K233483", "K230005", "K935929", "K922970", "K022640", "K111723", "K993564", "K083837", "K904680", "K122987", "K093918", "K920707", "K153460", "K081328", "K082664", "K091029", "K071350", "K181877", "K250723", "K110626", "K110389", "K141801", "K140775", "K120346", "K211518", "K161361", "K151260", "K071432", "K082186", "K060904", "K220116", "K970080", "K990829", "K094036", "K222837", "K230709", "K081944", "K090325", "K993648", "K061063", "K190634", "K133023", "K130637", "K933238", "K970233", "K093456", "K982657", "K970296", "K121774", "K033793", "K031610", "K101334", "K123632", "K003570", "K182397", "K150732", "K040252", "K924712", "K250385", "K182341", "K090521", "K133999", "K960379", "K152275", "K233668", "K953997", "K960970", "K101221", "K182972", "K163264", "K120242", "K242757", "K162561", "K220568", "K083489", "K220962", "K033997", "K220109", "K260244", "K913450", "K172236", "K181642", "K172386", "K212351", "K211738", "K082981", "K212027", "K973669", "K180694", "K982363", "K072748", "K043553", "K173862", "K210586", "K180416", "K024243", "K140944", "K021096", "K152694", "K172687", "K202835", "K221077", "K131092", "K241553", "K091509", "K993816", "K072800", "K060016", "K111388", "K133566", "K103618", "K160827", "K242947", "K901206", "K152181", "K041630", "K030504", "K170191", "K072195" ], "registration_number": [ "2939520", "3016445722", "3016257349", "3014443747", "3004742232", "1625425", "2648045", "3002631703", "3010041511", "3000279201", "1643817", "2024311", "3014254831", "3000126629", "1000121056", "3010280625", "1724474", "3008363989", "3006702495", "3004091615", "3008439199", "9612164", "3007695959", "1061124", "3004859241", "2244478", "3006946276", "3011137372", "3032916632", "3007048256", "3015124694", "3009756153", "1721676", "2183744", "3010273872", "3007284006", "3012669557", "3020968442", "2020394", "2134265", "3002807314", "3003862657", "3010173425", "3008814558", "1225687", "9616684", "3017896194", "2011171", "2183870", "3003708554", "3003780911", "2124215" ], "fei_number": [ "2939520", "3016445722", "3016257349", "1000512168", "3014443747", "3003094851", "3004742232", "1625425", "2648045", "3002631703", "3010041511", "3000279201", "1643817", "2024311", "3014254831", "3000126629", "1000121056", "3010280625", "3008363989", "3006702495", "3004091615", "3008439199", "3002095335", "3007695959", "1000136269", "3004859241", "3006946276", "3032916632", "3007048256", "3015124694", "3009756153", "1721676", "2183744", "3010273872", "3007284006", "3012669557", "3002913962", "3001451463", "3020968442", "2020394", "3002807314", "3003862657", "3002806434", "3005747797", "3008814558", "3017896194", "3002807036", "2011171", "2183870", "3003708554", "3003780911", "2124215" ], "device_name": "Catheter, Peripheral, Atherectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4875", "device_class": "2" } } ] }