{ "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": "143064", "product_res_number": "Z-0758-2016", "event_date_initiated": "2016-01-15", "event_date_posted": "2016-02-05", "recall_status": "Terminated", "event_date_terminated": "2017-03-02", "res_event_number": "73098", "product_code": "MCW", "k_numbers": [ "K152181" ], "product_description": "2.3mm Turbo-Power OTW, Manual, Model No 423-050\nProduct Usage\tThe Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300\" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300\" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300\" Excimer Laser System.", "code_info": "Lot CMP15J28A", "firm_fei_number": "3007284006", "recalling_firm": "Spectranetics Corp.", "address_1": "9965 Federal Dr", "city": "Colorado Springs", "state": "CO", "postal_code": "80921-3617", "additional_info_contact": "719-447-2318", "reason_for_recall": "The product is labeled with an expiration date that is past its shelf life.", "root_cause_description": "Error in labeling", "action": "Spectranectics sent a Medical Device Field Action letter dated January 15, 2016 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and set aside the affected product and contact Customer Service at 1-800-231-0978 to arrange a product exchange. Customers were asked to document the return on the enclosed Field Action Acknowledgement and Receipt Form. Customers with additional questions were instructed to contact their local Spectranetics sales representative.\nFor questions regarding this recall call 719-447-2318.", "product_quantity": "8 units", "distribution_pattern": "Nationwide distribution to Florida, North Carolina and Pennsylvania.", "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" } } ] }