{"url_path":"/fda/device/recalls/Z-2753-2026","section_key":"summary","section_title":"DEVICE Recall: Boston Scientific Corporation — FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-11","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2753-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Boston Scientific Corporation"},"word_count":92,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2753-2026\n\n**Recalling firm:** Boston Scientific Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-11\n**Report date:** 2026-07-29\n\n## Product\nFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter\n\n## Reason\nBoston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.\n\n## Affected lots\nGTIN/UDI 00810087180126, Serial Numbers:  1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.\n\n## Distribution\nInternational distribution in the countries of Italy, Austria, France, Germany, Belgium."}