{"recall":{"id":"fda-device-99230","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":"2026-06-11","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 00810087180126, Serial Numbers: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307.","quantity":"18 units","number":"Z-2750-2026","classification":"Class II"},{"name":"FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter","code":"GTIN 00191506042547, Serial Numbers: 106247020.","quantity":"1 units","number":"Z-2751-2026","classification":"Class II"},{"name":"FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter","code":"GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.","quantity":"11 units","number":"Z-2752-2026","classification":"Class II"}],"reason":"Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.","nationwide":false,"states":[],"units":"18 units; 1 units; 11 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=99230","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d85e569e1a4530d0","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=99230","record":[{"status":"Ongoing","city":"Saint Paul","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99230","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 states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.","recall_number":"Z-2750-2026","product_description":"FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter","product_quantity":"18 units","reason_for_recall":"Labeling discrepancy:  Devices distributed with Instructions For Use (IFU) did not include  FARAPOINT PFA catheter information.","recall_initiation_date":"20260611","center_classification_date":"20260717","report_date":"20260729","code_info":"GTIN 00810087180126, Serial Numbers: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307."},{"status":"Ongoing","city":"Saint Paul","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99230","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 states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.","recall_number":"Z-2751-2026","product_description":"FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter","product_quantity":"1 units","reason_for_recall":"Labeling discrepancy:  Devices distributed with Instructions For Use (IFU) did not include  FARAPOINT PFA catheter information.","recall_initiation_date":"20260611","center_classification_date":"20260717","report_date":"20260729","code_info":"GTIN 00191506042547, Serial Numbers:   106247020."},{"status":"Ongoing","city":"Saint Paul","state":"MN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99230","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 states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.","recall_number":"Z-2752-2026","product_description":"FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter","product_quantity":"11 units","reason_for_recall":"Labeling discrepancy:  Devices distributed with Instructions For Use (IFU) did not include  FARAPOINT PFA catheter information.","recall_initiation_date":"20260611","center_classification_date":"20260717","report_date":"20260729","code_info":"GTIN 00191506043643, Serial Numbers:   106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816."}]}}