{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "175739", "product_res_number": "Z-2542-2019", "event_date_initiated": "2019-08-21", "event_date_created": "2019-09-13", "recall_status": "Open, Classified", "res_event_number": "83558", "product_code": "LWS", "pma_numbers": [ "P110042S043" ], "product_description": "Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator", "code_info": "Model A209, Serial Number (Use Before Date) - 213729 (7/24/2019), 213859 (7/26/2019), 213891 (7/27/2019), 213896 (7/27/2019), 213898 (7/27/2019), 213901 (7/27/2019), 213902 (7/27/2019), 213904 (7/27/2019), 213910 (7/27/2019), 213919 (7/27/2019), 213921 (7/27/2019), 213937 (7/27/2019), 213938 (7/27/2019), 213943 (7/27/2019), 213946 (7/27/2019), 213961 (7/28/2019), 213972 (7/28/2019), 213975 (7/28/2019), 213976 (7/28/2019), 213979 (7/28/2019), 213982 (7/28/2019), 213983 (7/28/2019), 214020 (7/31/2019), 214030 (7/31/2019), 214032 (7/31/2019), 214036 (7/31/2019), 214042 (7/31/2019), 214083 (7/31/2019);", "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": "800-227-3422", "reason_for_recall": "Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.", "root_cause_description": "Component design/selection", "action": "Boston Scientific began notifying physicians of the recall on about 08/21/2019, via \"URGENT: MEDICAL DEVICE ADVISORY\" letter. The physicians associated with the affected devices were provide a letter with a list of affected model/serial numbers for patients which they have implanted and/or followed or sent to their center. The letter informed physicians of the potential for accelerated battery depletion on select active worldwide EMBLEM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs). Physicians were instructed to follow up with affected units implanted in patients by enroll and monitoring patients in LATITUDE to facilitate prompt detection of ERI/EOL during the interval between in-office device checks, perform a device follow-up every 3 months via remote or in-office interrogation, promptly investigate any suspected indication of accelerated depletion and contact Boston Scientific Technical Services for assistance as needed, and append the patients medical record with this letter to maintain awareness of this topic for the remaining service life of the device. \n\nPhysicians were also instructed to evaluate the potential for life-threatening harm due to accelerated depletion for patients are the greatest risk, and replace the affected device within 21 days of ERI and prophylactically for those devices in high risk patients. \n\nBoston Scientific also provided an advisory letter for all EMBLEM physicians in order to reiterate and summarize the battery management recommendations that exist in current EMBLEM S-ICD labeling. \n\nIncluded in the customer notification to each physician was (affected and advisory) is a patient advisory letter, which each physician can chose at their discretion to provide.\n\nQuestions and comments for US customers can be directed to Technical Services, Phone: 1.800.CARDIAC (227.3422) or Email: tech.services@bsci.com.\n\nIn addition, Boston Scientific worked with the Heart Rhythm Society who sent an email August 22, 20", "product_quantity": "28 devices", "distribution_pattern": "Nationwide distribution to Alabama, Arizona, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin, Wyoming. \n\nInternational distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Guam, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, , Lithuania, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. - Virgin Islands, United Arab Emirates, United Kingdom.", "openfda": { "pma_number": [ "P980023", "P010031", "P980050", "P030035", "P880006", "P910077", "P890061", "P970024", "P030054", "P910023", "P880086", "P980049", "P920015", "P960040", "P110042", "P900061", "P830060", "P940008", "P930035", "P910073", "P950022", "P980016", "P970013", "P010012", "P220012", "P050023", "P940024" ], "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2649622", "2133641", "2135338", "2030624", "3011120183", "3003932293", "1828132", "3009380063", "3013500228", "3005334138", "3008988055", "1225687", "3013288201", "3004105270", "2032521", "2183787", "3010273872", "3008159616", "9614453", "3018094310", "3013674629", "2182208", "9610139", "2648729", "3003276151", "3002807561", "2183744", "1423662", "2124215", "3002807314", "1000165971", "3004209178", "3006705815", "3008973940", "1028232", "9616693", "3008494315", "2022502", "2017865", "3004593495", "3014461810", "3004961578", "1000121056", "3012552532", "3033257494", "3010288227", "3003120897", "3002806603", "3013596024", "3015453963", "2011171", "3015544746" ], "fei_number": [ "2649622", "3000206435", "3011120183", "3003932293", "1828132", "3009380063", "3013500228", "3005334138", "3002618605", "3008988055", "3013288201", "3004105270", "2183787", "3010273872", "3002807576", "3008159616", "3005700659", "3018094310", "3013674629", "2182208", "3000215273", "2648729", "3003276151", "3002807561", "2183744", "2124215", "3002807314", "1000165971", "3006705815", "3008973940", "1028232", "3000203466", "3004593495", "2022502", "2017865", "3014461810", "3003574398", "3004961578", "1000121056", "3012552532", "3033257494", "3008377825", "3010288227", "3002806500", "3003120897", "3001451463", "3002806603", "3013596024", "3015453963", "2011171", "3015544746", "3004369318" ] } } ] }