{ "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": "139896", "product_res_number": "Z-0200-2016", "event_date_initiated": "2015-09-29", "event_date_posted": "2015-11-02", "recall_status": "Terminated", "event_date_terminated": "2016-03-09", "res_event_number": "72115", "product_code": "DRF", "k_numbers": [ "K102588" ], "product_description": "Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.", "code_info": "Lot U531", "firm_fei_number": "2182208", "recalling_firm": "Medtronic Inc.", "address_1": "8200 Coral Sea St Ne", "city": "Saint Paul", "state": "MN", "postal_code": "55112-4391", "additional_info_contact": "888-843-8301", "reason_for_recall": "64 units of Achieve Electrical Cables were shipped with a potential sterility breach.", "root_cause_description": "Under Investigation by firm", "action": "Medtronic sales reps began notifying customers on 9/29/2015. Customers were told of the issue and were requested to quarantine and return un-used product. A follow-up Urgent Medical Device Recall letter was hand delivered beginning 10/6/2015. The letter again described the issue, identified affected product and asked that un-used product be returned to Medtronic. A response form was asked to be returned to Medtronic. Customer with questions can contact Medtronic AF Solutions at 888-843-8301", "product_quantity": "64 units", "distribution_pattern": "Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.", "openfda": { "k_number": [ "K011734", "K031161", "K212593", "K900765", "K903136", "K061468", "K923916", "K130602", "K000753", "K992912", "K113213", "K013484", "K982415", "K964272", "K010471", "K933417", "K945229", "K984150", "K962307", "K233207", "K770709", "K093376", "K211494", "K951347", "K082061", "K120544", "K951744", "K011847", "K101623", "K954390", "K080179", "K953750", "K915640", "K122461", "K171277", "K160335", "K211327", "K250310", "K893611", "K233900", "K102588", "K002333", "K211375", "K913375", "K230503", "K252794", "K802058", "K052083", "K191880", "K042105", "K953768", "K991025", "K220796", "K090898", "K072012", "K133028", "K081803", "K011766", "K050877", "K955802", "K012520", "K240366", "K201445", "K844805", "K891908", "K940168", "K233397", "K190132", "K990958", "K812944", "K892207", "K991878", "K192037", "K881966", "K823434", "K971504", "K923915", "K881853", "K102721", "K043257", "K150631", "K203261", "K915159", "K021421", "K250590", "K931794", "K190980", "K982835", "K972803", "K011361", "K911065", "K060047", "K991531", "K943257", "K033050", "K991001", "K053582", "K002976", "K873995", "K033963", "K904747", "K834602", "K894500", "K955847", "K992373", "K946333", "K061463", "K981642", "K192360", "K193632", "K982232", "K970853", "K823361", "K022380", "K061678", "K211219", "K960542", "K924109", "K953185", "K926549", "K940167", "K770341", "K042998", "K162892", "K924108", "K971975", "K091370", "K911140", "K101955", "K151622", "K770477", "K042775", "K953663", "K991060", "K980961", "K932388", "K874208", "K210313", "K914278", "K183649", "K160390", "K143481", "K153139", "K183547", "K030627", "K965066", "K090120", "K902228", "K942379", "K983653", "K973639", "K182386", "K961924", "K914460", "K030852", "K062251", "K933450", "K992965", "K203793", "K993698", "K903880", "K101345", "K151139", "K900452", "K955817", "K953651", "K232651", "K963074", "K954651", "K895916", "K101991", "K081258", "K933451", "K872231", "K831528", "K081576", "K915563", "K161769", "K971265", "K924163", "K003452", "K060757", "K080425", "K905831", "K183632" ], "pma_number": [ "P990071", "P950005", "P990025" ], "registration_number": [ "3013403214", "3012693387", "2029275", "3012179728", "3011024991", "2182208", "3008497357", "3003678543", "2124215", "3011610434", "2028523", "3003289723", "3009337690", "3010705768", "3016678045", "2648623", "3008093809", "8043831", "3027305778", "3015537323", "1000121056", "2024311", "3005402529", "3013400708", "2030404", "1721686", "9680001", "3008824097", "2032112", "3006891611", "2184149", "2184009", "3025341484", "3007616088", "2024024", "3004859241", "3027815", "1450662", "3009393076", "2031044", "1721983", "3037050339", "9673241", "1313046", "3032391", "3005334138", "9617601", "3008452825", "2649622", "3007695959", "3017060084", "1721676", "2182269", "3010532612", "3018258443", "3009243923", "2126666", "1061124", "1650907", "3006634485", "9610139", "2135338", "3044156918", "3015859709", "3011276773", "1018233", "3019807891", "2032098", "1643817", "3009888344", "1317547", "1927197", "3006082230", "3013162291", "1928237", "2183744", "1319639", "3019751610", "1028232", "3013581838", "9617592", "3010273872", "2030624", "9680794", "9681260", "3014368660", "2528981", "3009254201", "3013300026" ], "fei_number": [ "3013403214", "3005700659", "1000116158", "1000138054", "3012693387", "3001236763", "3012179728", "1000127185", "3011024991", "2182208", "3008497357", "3003678543", "2124215", "3011610434", "3003289723", "3009337690", "3010705768", "3016678045", "3003248396", "3000206435", "2648623", "1000519796", "1000064530", "3008093809", "3002468371", "3003076831", "3015537323", "1000121056", "3027305778", "2024311", "3005402529", "3013400708", "1721686", "3008824097", "3006891611", "1000306431", "3002806565", "3002806500", "3025341484", "3007616088", "2024024", "3004859241", "3002808439", "1450662", "3003058448", "3009393076", "3002681132", "3037050339", "1313046", "1000139754", "3005334138", "3002534070", "3008452825", "2649622", "3007695959", "3017060084", "1721676", "1000125147", "3003737899", "1000512168", "2182269", "3010532612", "3018258443", "3009243923", "2126666", "3006634485", "3044156918", "3015859709", "3011276773", "1018233", "3019807891", "1643817", "3009888344", "1317547", "1927197", "3006082230", "3002299608", "3013162291", "1928237", "2183744", "3019751610", "1028232", "3013581838", "3010273872", "3002808445", "3014368660", "2528981", "3009254201", "3013300026" ], "device_name": "Catheter, Electrode Recording, Or Probe, Electrode Recording", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1220", "device_class": "2" } } ] }