{ "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": "2026-04-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Plano", "state": "TX", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "78154", "recalling_firm": "St. Jude Medical, Inc.", "address_1": "6901 Preston Rd", "address_2": "", "postal_code": "75024-2508", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)", "recall_number": "Z-0024-2018", "product_description": "Proclaim DRG Implantable Pulse Generator Model 3664", "product_quantity": "1744 devices", "reason_for_recall": "Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.", "recall_initiation_date": "20170912", "center_classification_date": "20171017", "termination_date": "20200416", "report_date": "20171025", "code_info": "Serials implanted prior to September 12, 2017 are considered part of this advisory; Serial Numbers - AAP114.1 AAP267.1 AAP380.1 AAT623.1 ABM656.1 ABT952.1 ACD631.1 ACE905.1 ADJ588.1 ADJ614.1 ADJ842.1 ADJ852.1 ADJ855.1 ADJ863.1 ADJ872.1 ADJ910.1 ADK057.1 ADK078.1 ADK116.1 ADK186.1 ADK293.1 ADN214.1 ADN311.1 ADN340.1 ADN347.1 ADN376.1 ADN398.1 ADR256.1 ADR258.1 ADR260.1 ADR262.1 ADR289.1 ADR299.1 ADR302.1 ADR313.1 ADR362.1 ADR364.1 ADR365.1 ADR400.1 ADR401.1 ADR405.1 ADR410.1 ADR416.1 ADR421.1 ADR433.1 ADR434.1 ADR453.1 ADR457.1 ADR460.1 ADR461.1 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