{ "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-1443-2021", "product_description": "BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.", "product_quantity": "1000 UNITS", "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": "Serial Number 60713356 60713357 60713358 60713359 60713360 60713361 60713362 60713363 60713364 60713365 60715282 60715285 60715286 60715287 60715288 60715292 60715293 60715296 60715299 60715300 60715301 60716193 60716194 60716195 60716196 60716197 60716198 60716199 60716201 60716203 60716204 60716205 60716208 60716210 60716597 60716598 60716599 60716600 60716603 60716604 60716606 60716608 60716611 60716612 60716613 60716615 60716616 60716647 60716648 60716651 60716652 60716653 60716654 60716655 60716656 60717982 60717984 60717985 60717988 60717989 60717994 60717995 60717996 60717998 60717999 60718001 60718002 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