{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Lake Oswego", "state": "OR", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "87549", "recalling_firm": "BIOTRONIK Inc", "address_1": "6024 Jean Rd", "address_2": "N/A", "postal_code": "97035-5571", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US: Nationwide OUS: Worldwide", "recall_number": "Z-1442-2021", "product_description": "BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.", "product_quantity": "N/A", "reason_for_recall": "There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)", "recall_initiation_date": "20210308", "center_classification_date": "20210421", "termination_date": "20230425", "report_date": "20210428", "code_info": "Affected Serial Number: 60744585 60744586 60744588 60744589 60744590 60744591 60744592 60744593 60744594 60744595 60744596 60744597 60744598 60744599 60744600 60744602 60744603 60744605 60744606 60744607 60744609 60744610 60744611 60744612 60744613 60744614 60744735 60744736 60744739 60744740 60744741 60744742 60744744 60744746 60744747 60744748 60744749 60744751 60744752 60744753 60745675 60745676 60745678 60745679 60745680 60745681 60745682 60745895 60745896 60745897 60745898 60745899 60745900 60745901 60745902 60745903 60745905 60745906 60745907 60745912 60745913 60745914 60746065 60746066 60746069 60746070 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