{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "41698", "product_res_number": "Z-0127-06", "event_date_initiated": "2005-09-01", "event_date_posted": "2005-11-05", "recall_status": "Terminated", "event_date_terminated": "2006-11-13", "res_event_number": "33323", "product_code": "KRD", "k_numbers": [ "K031810" ], "product_description": "AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.", "code_info": "The three lots that were distributed are identified as Lot no. M05F10-11, M05F15-12 and M05F02-47.", "firm_fei_number": "3005334138", "recalling_firm": "AGA Medical Corporation", "address_1": "682 Mendelssohn Ave N", "city": "Golden Valley", "state": "MN", "postal_code": "55427-4306", "reason_for_recall": "Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.", "root_cause_description": "Other", "action": "Urgent Recall letters, dated 09/01/05, were sent to affected customers via email, facsimile and with follow-up delivery via USPS. OUS customers were notified via Federal Express. The letter described the situation, the lots being recalled and included a response form that was to be faxed back to AGA Medical.", "product_quantity": "81", "distribution_pattern": "OUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom", "openfda": { "k_number": [ "K250276", "K123712", "K150964", "K250079", "K182390", "K882136", "K112103", "K252812", "K202850", "K183578", "K220567", "K181300", "K034068", "K230706", "K133626", "K130577", "K162524", "K060078", "K223050", "K213385", "K063619", "K260508", "K173891", "K181051", "K143038", "K914786", "K242608", "K220699", "K102912", "K152157", "K240261", "K113658", "K141209", "K250209", "K133208", "K153778", "K151358", "K123384", "K203025", "K192083", "K212817", "K150108", "K253677", "K083091", "K192480", "K191680", "K234123", "K940982", "K212057", "K093813", "K091882", "K240873", "K200083", "K133282", "K220383", "K150958", "K151187", "K093002", "K122543", "K090624", "K120630", "K150931", "K210562", "K183120", "K892446", "K171946", "K261488", "K031810", "K141313", "K242794", "K242507", "K160219", "K150402", "K260635", "K123696", "K993455", "K253511", "K123803", "K250133", "K102365", "K955293", "K081465", "K071699", "K191532", "K181021", "K130307", "K854273", "K140796", "K052834", "K071939", "K073544", "K182944", "K141378", "K213200", "K132578", "K232934", "K153102", "K052742", "K113266", "K253376", "K102714", "K133924", "K111307", "K992121", "K171845", "K150870", "K061790", "K231554", "K213398", "K113651", "K132083", "K940189", "K071125", "K132675", "K964112", "K172372", "K091952", "K250971", "K133237", "K050470", "K110295", "K073417", "K040342", "K122316", "K162373", "K043371", "K251383", "K090046", "K261866", "K150876", "K151676", "K120816" ], "pma_number": [ "P780011" ], "registration_number": [ "", "3044156918", "2024311", "3008307705", "3005580113", "3027595249", "2245304", "1000393132", "3005735987", "3025434462", "3012931345", "2020394", "9681260", "3012179728", "2133641", "3010079067", "3013353964", "3013758550", "3008264254", "3012276280", "1721676", "9617601", "3033589330", "1000121056", "3009905888", "3017961114", "3013556777", "3015151147", "2135147", "3007113487", "3007738736", "3015550451", "9614654", "3004091615", "9615728", "2134812", "3014162263", "3012120143", "1220477", "2124215", "2029214", "3008881809", "1531062", "3013505221", "3007628272", "1820334", "3015225571", "2030624", "2032112", "3015453963", "3000143502", "2134265", "3005168196", "3016444913", "2183744", "3008853977", "1048735", "2183870", "3004859241", "1928237", "3011137372", "3002807295", "3009761573", "3015615738", "3008114965", "3031550970", "2011171", "3012536737", "3016609702", "3009526575", "3016245399", "3010178296", "3015531723", "3033841272", "2184009", "3007029079", "9616684", "3042953152", "3008837339", "3013944123", "2030598", "3031240343", "3012448339", "1225687", "3010173425", "9610849", "3002807314", "3006950086", "3005111382", "3009380063", "3002808486", "3010273872", "1423662", "9616662", "3008262715", "3030003849", "3016688836", "2024024", "2953359", "3015309643", "1424778", "2029275", "3016591327", "1721504" ], "fei_number": [ "", "3044156918", "3002827704", "2024311", "3008307705", "3005580113", "3027595249", "2245304", "1000518731", "1000393132", "3005735987", "3025434462", "3002095335", "1721504", "3012931345", "2020394", "3012179728", "3000215273", "3002808761", "3000203466", "3010079067", "3003473227", "3013353964", "1000306431", "3013758550", "3008264254", "3000206435", "3012276280", "1721676", "3033589330", "3000335778", "1000121056", "3009905888", "3005334138", "3013556777", "3003076831", "3015151147", "3017961114", "3007113487", "3007738736", "3015550451", "3004091615", "3014162263", "3012120143", "1220477", "2124215", "3008881809", "3013505221", "3007628272", "1820334", "3015225571", "3015453963", "3000143502", "3005168196", "3000215205", "3016444913", "2183744", "3008853977", "1048735", "3002913962", "2183870", "3004859241", "1928237", "3002807295", "3009761573", "3015615738", "3008114965", "3031550970", "2011171", "3012536737", "3016609702", "3009526575", "3016245399", "3015531723", "3033841272", "3002806565", "3007029079", "3003110073", "3042953152", "3002534070", "3008837339", "3013944123", "3031240343", "3002807036", "3012448339", "3002807314", "3001451463", "3002768455", "3006950086", "1000116158", "3005111382", "3002807391", "3009380063", "3002808486", "3010273872", "3008262715", "1000220862", "3030003849", "3016688836", "2024024", "3015309643", "3002808904", "3016591327", "3005747797" ], "device_name": "Device, Vascular, For Promoting Embolization", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3300", "device_class": "2" } } ] }