{"url_path":"/fda/device/recalls/Z-2752-2026","section_key":"summary","section_title":"DEVICE Recall: Boston Scientific Corporation — FARASTAR PFA Generator, Product ID M004PFCE61M460; 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-2752-2026%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":90,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2752-2026\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 PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter\n\n## Reason\nLabeling discrepancy:  Devices distributed with Instructions For Use (IFU) did not include  FARAPOINT PFA catheter information.\n\n## Affected lots\nGTIN 00191506043643, Serial Numbers:   106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.\n\n## Distribution\nInternational distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland."}