{ "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. 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UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05", "report_date": "20161116", "classification": "Class I", "openfda": {}, "recalling_firm": "Micro Therapeutics Inc, Dba Ev3 Neurovascular", "recall_number": "Z-0309-2017", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "75358", "termination_date": "20171011", "more_code_info": "", "recall_initiation_date": "20161005", "postal_code": "92618-1811", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }