{"recall":{"id":"fda-device-99524","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Boston Scientific Corporation recalls 3 products","firm":"Boston Scientific Corporation","date":"2026-08-06","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)","code":"UDI-DI: 00802526613838","quantity":"N/A","number":"Z-3081-2026","classification":"Class II"},{"name":"LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)","code":"UDI-DI: 00802526613883","quantity":"N/A","number":"Z-3082-2026","classification":"Class II"},{"name":"LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)","code":"UDI-DI: 00802526613852","quantity":"N/A","number":"Z-3083-2026","classification":"Class II"}],"reason":"There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution.","nationwide":true,"states":[],"units":"N/A; N/A; N/A","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99524","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"751c6eaf4eabffaa","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99524","record":[{"status":"Ongoing","city":"Saint Paul","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99524","recalling_firm":"Boston Scientific Corporation","address_1":"4100 Hamline Ave N","address_2":"N/A","postal_code":"55112-5700","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-3081-2026","product_description":"LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)","product_quantity":"N/A","reason_for_recall":"There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.","recall_initiation_date":"20260806","center_classification_date":"20260902","report_date":"20260909","code_info":"UDI-DI: 00802526613838","more_code_info":""},{"status":"Ongoing","city":"Saint Paul","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99524","recalling_firm":"Boston Scientific Corporation","address_1":"4100 Hamline Ave N","address_2":"N/A","postal_code":"55112-5700","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-3082-2026","product_description":"LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)","product_quantity":"N/A","reason_for_recall":"There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.","recall_initiation_date":"20260806","center_classification_date":"20260902","report_date":"20260909","code_info":"UDI-DI: 00802526613883","more_code_info":""},{"status":"Ongoing","city":"Saint Paul","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99524","recalling_firm":"Boston Scientific Corporation","address_1":"4100 Hamline Ave N","address_2":"N/A","postal_code":"55112-5700","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution.","recall_number":"Z-3083-2026","product_description":"LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)","product_quantity":"N/A","reason_for_recall":"There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.","recall_initiation_date":"20260806","center_classification_date":"20260902","report_date":"20260909","code_info":"UDI-DI: 00802526613852","more_code_info":""}]}}