{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "49019", "product_res_number": "Z-0298-2007", "event_date_initiated": "2006-10-06", "event_date_posted": "2006-12-19", "recall_status": "Terminated", "event_date_terminated": "2012-03-26", "res_event_number": "36619", "product_code": "DXY", "pma_numbers": [ "P880086" ], "product_description": "St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)", "code_info": "All Devices (all serial numbers for the devices referenced in the advisory.)", "firm_fei_number": "2017865", "recalling_firm": "St Jude Medical CRMD", "address_1": "15900 Valley View Ct", "city": "Sylmar", "state": "CA", "postal_code": "91342-3577", "additional_info_contact": "Nestor Kusnierz\n818-493-2587", "reason_for_recall": "St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.", "root_cause_description": "Other", "action": "The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th.\n\nIn the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar.\n\nIn addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on St. Jude's website, www.sim.com\n\nCompletion of this advisory is estimated to be three months after its initiation.", "product_quantity": "199,065", "distribution_pattern": "Worldwide in USA, ARGENTINA, AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, EUROPE, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GUATEMALA, HONG KONG, ICELAND, INDIA, ISRAEL, ITALY, JAPAN, JORDAN, SOUTH KOREA, LATVIA, LICHTENSTEIN, LUXEMBURG, MALAYSIA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PORTUGAL, SAUDI ARABIA, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, UNITED KINGDOM &\nVENEZUELA", "openfda": { "k_number": [ "K792052", "K781738", "K820939", "K760669", "K841635", "K772241", "K860922", "K800838", "K853651", "K863898", "K903081", "K810036", "K862037", "K884420", "K852431", "K810383", "K894494", "K782161", "K821003", 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"P880006", "P880086", "P870054", "P060027", "P960004", "P980049", "P950037", "P890039", "P140033" ], "registration_number": [ "3003120897", "3005334138", "3018094310", "2032521", "2133641", "2135338", "2124215", "3033257494", "1000165971", "3002806603", "3009380063", "2024024", "3008159616", "3006705815", "3008483389", "2649622", "2182208", "9610139", "2648729", "3004593495", "2017865", "3008494315", "3008973940", "3013288201", "9614453", "3012552532", "1028232", "3004209178" ], "fei_number": [ "3003120897", "3005334138", "3018094310", "2124215", "3033257494", "1000165971", "3005700659", "3003574398", "3002806603", "3002807576", "3009380063", "2024024", "3008159616", "3004369318", "3006705815", "3008483389", "2649622", "2182208", "3008377825", "3002806500", "2648729", "3004593495", "2017865", "3008973940", "3013288201", "3000203466", "3012552532", "1028232" ], "device_name": "Implantable Pacemaker Pulse-Generator", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3610", "device_class": "3" } } ] }