{ "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": "150921", "product_res_number": "Z-0661-2017", "event_date_initiated": "2016-10-31", "event_date_posted": "2016-11-28", "recall_status": "Terminated", "event_date_terminated": "2017-04-18", "res_event_number": "75617", "product_code": "MCW", "k_numbers": [ "K140775" ], "product_description": "Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01\nThe Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.", "code_info": "FBD16D01A; FBD16F20A; FBD16D11A; FBD16F29A; FBD16D14A; FBD16G18A; FBD16D23A; FBD16G29A; FBD16E05A; FBD16H03A; FBD16E11A; FBD16H26A FBD16E19A; FBD16J06A; FBD16E26A; FBD16J21A; FBD16F03A; FBD16J26A; FBE16C30A; FBE16H24A; FBE16E25A; FBE16J14A; FBE16F15A; FAY16C29A; FAY16G14A; FAY16D08A; FAY16G29A; FAY16D26A; FAY16H23A; FAY16E17A; FAY16H31A; FAY16F08A; FAY16J23B; FAY16G01A; FBF16D27A; FBF16G07A FBF16E12A\t; FBF16H10B; FBF16F17A; FBF16J16A; FAZ16C31A; FAZ16G25A; FAZ16D14A\t; FAZ16H01A; FAZ16D25A; FAZ16H22A; FAZ16E06A; FAZ16H30A FAZ16F24B; FAZ16J20A; FAZ16F27A; FBG16E02A; FBG16H31A; FBG16F23A; CBA16H19A; FBA16F27A; CBA16H19B; FBA16G11A; CBA16H19C; FBA16G15A; FBA16D04A; FBA16G19A; FBA16D06A; FBA16G27B; FBA16D18A; FBA16H02A FBA16D21A; FBA16H08A; FBA16E09A; FBA16H17A; FBA16E10A; FBA16J02A FBA16E13A; FBA16J07A; FBA16E19A; FBA16J19A; FBA16F07A; FBA16J22A; FBA16F21A; FBE16E02A; FBE16G06A; FBE16G20A; FAZ16E26A; FAZ16G12A; FBA16D29A; FBA16F16B;", "firm_fei_number": "3007284006", "recalling_firm": "Spectranetics Corporation", "address_1": "9965 Federal Drive", "city": "Colorado Springs", "state": "CO", "postal_code": "80921-3617", "additional_info_contact": "Lindsay K Pack\n719-447-2469", "reason_for_recall": "Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.", "root_cause_description": "Packaging", "action": "Spectranectics sent an Urgent Medical Device Recall letter dated October 31, 2016, to all affected consignees. Consignees were instructed to discontinue use of the potentially impacted lots and return the product for replacement. Consignees were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return of any remaining product in inventory. Customers with questions were instructed to call 1-800-231-0978, Option 2. For questions regarding this recall call 719-651-8517.", "product_quantity": "14,624 units", "distribution_pattern": "Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.", "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" } } ] }