{ "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": "178074", "product_res_number": "Z-0730-2020", "event_date_initiated": "2019-11-14", "event_date_created": "2019-12-20", "recall_status": "Open, Classified", "res_event_number": "84228", "product_code": "NIP", "product_description": "Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. \n The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at each end. \n\nThe S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stents are designed to open to a preprogrammed diameter at body temperature. \nThere are two delivery system configurations S.M.A.R.T. CONTROL and S.M.A.R.T. The stent is contained within the outer sheath of the delivery system. Once the distal end of the delivery system reaches the treatment site, the outer sheath of the delivery system is retracted to expose the stent and start its self-expansion. For the S.M.A.R.T. CONTROL Stent System, sheath retraction is achieved by grasping the handle in a fixed position with the tuning dial held between the thumb and index fingers, and rotating the tuning dial in a clockwise direction until the distal end of the stent is visibly apposed to the vessel wall. For the S.M.A.R.T. Stent System, sheath retraction is achieved by grasping the inner shaft in a fixed position and moving the outer sheath proximally relative t the inner shaft.", "code_info": "All Lot Codes. Affected SKUs: C06020MB, C06020MV, C06020SB, C06020SV, C06030MB, C06030MV, C06030SB, C06030SV, C06040MB, C06040MV, C06040SB, C06040SV, C06060MB, C06060MV, C06060SB, C06060SV, C06080MB, C06080MV, C06080SB, C06080SV, C06100MB, C06100MV, C06100SB, C06100SV, C07020MB, C07020MV, C07020SB, C07020SV, C07030MB, C07030MV, C07030SB, C07030SV, C07040MB, C07040MV, C07040SB, C07040SV, C07060MB, C07060MV, C07060SB, C07060SV, C07080MB, C07080MV, C07080SB, C07080SV, C07100MB, C07100MV, C07100SB, C07100SV, C08020MB, C08020MV, C08020SB, C08020SV, C08030MB, C08030MV, C08030SB, C08030SV, C08040MB, C08040MV, C08040SB, C08040SV, C08060MB, C08060MV, C08060SB, C08060SV, C08080MB, C08080MV, C08080SB, C08080SV, C08100MB, C08100MV, C08100SB, C08100SV, C09020MB, C09020MV, C09020SB, C09020SV, C09030MB, C09030MV, C09030SB, C09030SV, C09040MB, C09040MV, C09040SB, C09040SV, C09060MB, C09060MV, C09060SB, C09060SV, C09080MB, C09080MV, C09080SB, C09080SV, C09100MB, C09100MV, C09100SB, C09100SV, C10020MB, C10020MV, C10020SB, C10020SV, C10030MB, C10030MV, C10030SB, C10030SV, C10040MB, C10040MV, C10040SB, C10040SV, C10060MB, C10060MV, C10060SB, C10060SV, C10080MB, C10080MV, C10080SB, C10080SV, C10100MB, C10100MV, C10100SB, C10100SV, C12020MB, C12020MV, C12020SB, C12020SV, C12030MB, C12030MV, C12030SB, C12030SV, C12040MB, C12040MV, C12040SB, C12040SV, C12060MB, C12060MV, C12060SB, C12060SV, C12080MB, C12080MV, C12080SB, C12080SV, C14030MB, C14030MV, C14030SB, C14030SV, C14040MB, C14040MV, C14040SB, C14040SV, C14060MB, C14060MV, C14060SB, C14060SV, C14080MB, C14080MV, C14080SB, C14080SV.", "firm_fei_number": "3004008697", "recalling_firm": "Cardinal Health Inc.", "address_1": "7000 Cardinal Pl", "city": "Dublin", "state": "OH", "postal_code": "43017-1091", "additional_info_contact": "Cordis Endovascular Medical Info Line\n877-338-4235", "reason_for_recall": "Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is \"MRI Conditional\" not \"MRI Safe\".", "root_cause_description": "Under Investigation by firm", "action": "Customers were notified with a Medical Device Correction letter. The letter was sent via overnight delivery beginning 11/14/2019. The letter identified affected product, provided a description of the problem, and asked that a copy of the letter be retained where the product is stored. Customer were asked to completed and return an Acknowledgement Form. Questions can be directed to the Cordis Endovascular Medical Information Line 877-DEVICE5 (877-338-4235) Monday through Friday 9:00 am - 5:00 pm EST.", "product_quantity": "267,247 units total (262,641 OUS, 4,606 US)", "distribution_pattern": "Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Repulic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saint-Barthelemy, Saudia Arabia, Sinapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela.", "openfda": { "pma_number": [ "P120020", "P140028", "P140002", "P050017", "P160004", "P110023", "P040037", "P120002", "P180003", "P070014", "P000033", "P160025", "P110040" ], "registration_number": [ "3010432890", "2011171", "1000121056", "3010155661", "1225687", "3014656749", "1721686", "2017233", "3008328690", "1643817", "3005580113", "1048735", "3010220595", "2124215", "1016427", "9616099", "3009526575", "3011632150", "1721676", "2024168", "2183744", "3004091615", "8010026", "3006946276", "9681834", "3002807090", "2939561", "3010273872", "2020394", "9681442", "3002807314", "9681260", "3001845648", "2134265", "8043892", "3005941719", "2183870", "3002504068", "3011574793" ], "fei_number": [ "3010432890", "2011171", "1000121056", "3010155661", "3014656749", "1721686", "2017233", "3008328690", "3002808050", "1643817", "3001451463", "3003528016", "3002806368", "3005580113", "1048735", "3010220595", "2124215", "3002095335", "1016427", "2828", "3009526575", "3002806565", "3011632150", "1721676", "2024168", "2183744", "3004091615", "3006946276", "3002808327", "3006003617", "3010273872", "2020394", "3002807314", "3001845648", "3004635528", "3002807111", "2183870", "3002504068", "3011574793" ], "device_name": "Stent, Superficial Femoral Artery", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }