{ "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": "168782", "product_res_number": "Z-0474-2019", "event_date_initiated": "2018-11-01", "event_date_created": "2018-11-16", "recall_status": "Terminated", "event_date_terminated": "2019-11-04", "res_event_number": "81471", "product_code": "LWS", "pma_numbers": [ "P110042" ], "product_description": "The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System\n\n The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.", "code_info": "SQ-RX Pulse Generator Model 1010", "firm_fei_number": "2124215", "recalling_firm": "Boston Scientific Corporation", "address_1": "4100 Hamline Ave N Bldg 3", "city": "Saint Paul", "state": "MN", "postal_code": "55112-5700", "additional_info_contact": "United States Technical Services\n800-227-3422", "reason_for_recall": "Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.", "root_cause_description": "Device Design", "action": "The firm, Boston Scientific, sent an \"Important Medical Device\nInformation\" letter to customers on November 5, 2018 by hand, email via our sales representatives or Federal Express or Courier. The letter described the product, problem and actions to be taken. We will reconcile that 100% of the identified customers /customer representatives signed for the letter, or the letter has been confirmed to be delivered. Boston Scientific will post the product advisory letter on our website, within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/product-advisories.html. The customers were instructed to do the following: \nYour doctor has been notified to look for this possible change, so please go to all scheduled defibrillator checks and clinic visits. As always, if you or your family hear beeping from your device, please contact your heart clinic as soon as possible. Your doctor can confirm your ability to hear and recognize this sound during an appointment.\n\nIf you have additional questions regarding this information or would like to report a clinical event, please contact your Boston Scientific representative or\nTechnical Services, or the Recall Contact at 651-582-3494 or email: Heather.Young@bsci.com.", "product_quantity": "12,900", "distribution_pattern": "US Nationwide Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.", "openfda": { "pma_number": [ "P010031", "P900061", "P980016", "P880086", "P940008", "P030035", "P970024", "P980050", "P010012", "P830060", "P970013", "P110042", "P030054", "P930035", "P910023", "P910073", "P890061", "P910077", "P880006", "P980049", "P050023", "P950022", "P960040", "P920015", "P980023", "P940024", "P220012" ], "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "3015453963", "2011171", "3008159616", "1000121056", "1225687", "3008988055", "3010288227", "3018094310", "9616693", "3013288201", "3003932293", "3003120897", "2017865", "2182208", "3013500228", "3005334138", "3006705815", "3004105270", "2124215", "3008494315", "1423662", "9614453", "2135338", "2649622", "2183787", "2648729", "3003276151", "3014461810", "3015544746", "3004209178", "3008973940", "2183744", "1028232", "3013596024", "3012552532", "1828132", "3004961578", "2133641", "3010273872", "3002806603", "2030624", "2022502", "3002807314", "3002807561", "3004593495", "3033257494", "2032521", "3009380063", "3013674629", "3011120183", "9610139", "1000165971" ], "fei_number": [ "3005700659", "3015453963", "3003574398", "3002618605", "2011171", "3008159616", "1000121056", "3008988055", "3010288227", "3018094310", "3013288201", "3001451463", "3003932293", "3003120897", "2017865", "2182208", "3013500228", "3005334138", "3006705815", "3004105270", "2124215", "3002807576", "2649622", "2183787", "2648729", "3000203466", "3003276151", "3014461810", "3015544746", "3008973940", "2183744", "3004369318", "1028232", "3013596024", "3012552532", "1828132", "3002806500", "3004961578", "3010273872", "3000215273", "3000206435", "3002806603", "2022502", "3002807561", "3002807314", "3004593495", "3033257494", "3009380063", "3013674629", "3008377825", "3011120183", "1000165971" ] } } ] }