{ "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": "131583", "product_res_number": "Z-0580-2015", "event_date_initiated": "2014-11-20", "event_date_posted": "2014-12-10", "recall_status": "Terminated", "event_date_terminated": "2016-08-11", "res_event_number": "69818", "product_code": "DRF", "k_numbers": [ "K122461" ], "product_description": "IntellaMap Orion High Resolution Mapping Catheter;\nMaterial number: M004RC64S0; Catalog number RC64S;\n\nIs indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.", "code_info": "Lot numbers: 17075550, 17075981, 17083913, 17088826, 17094081, 17101668, 17208445, 17218467, 17251661, 17258617, 17274937, 17292792, and 17308586. Expiry Dates from June 25, 2015 to September 24, 2015.", "firm_fei_number": "3001236349", "recalling_firm": "Boston Scientific Corp", "address_1": "150 Baytech Dr", "city": "San Jose", "state": "CA", "postal_code": "95134-2302", "additional_info_contact": "Mark Lanz\n763-494-2895", "reason_for_recall": "Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.", "root_cause_description": "Device Design", "action": "Urgent Medical Device Recall Correction Notification letters were sent on November 19, 2014 by overnight delivery. The letter identified the affected product and the problem. Customers were asked to read the Notification completely and ensure that all users are aware. The letter provides users with steps to mitigate the risk in the event that the identified problem occurs. Customers were also asked to complete and return the Customer Acknowledgement Form. A local sales representative can answer questions regarding the Field Correction.", "product_quantity": "184 units", "distribution_pattern": "Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.", "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" } } ] }