{"recall":{"id":"fda-device-99251","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Boston Scientific Corporation recalls FARASTAR Ablation Generator EU","firm":"Boston Scientific Corporation","date":"2026-06-11","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter","code":"GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.","quantity":"6 units","number":"Z-2753-2026","classification":"Class II"}],"reason":"Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"International distribution in the countries of Italy, Austria, France, Germany, Belgium.","nationwide":false,"states":[],"units":"6 units","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=99251","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"151a2e1084cbd540","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=99251","record":[{"status":"Ongoing","city":"Saint Paul","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99251","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":"Letter","distribution_pattern":"International distribution in the countries of Italy, Austria, France, Germany, Belgium.","recall_number":"Z-2753-2026","product_description":"FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter","product_quantity":"6 units","reason_for_recall":"Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.","recall_initiation_date":"20260611","center_classification_date":"20260717","report_date":"20260729","code_info":"GTIN/UDI 00810087180126, Serial Numbers:  1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172."}]}}