{"url_path":"/fda/device/recalls/Z-2978-2026","section_key":"summary","section_title":"DEVICE Recall: Boston Scientific Corporation — Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus,  Material Number SR-250-NPS; Percutaneous catheter","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-09","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2978-2026%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":192,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2978-2026\n\n**Recalling firm:** Boston Scientific Corporation\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-09\n**Report date:** 2026-08-26\n\n## Product\nBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus,  Material Number SR-250-NPS; Percutaneous catheter\n\n## Reason\nPotential for arterial sheath tip separation or partial tip separation during use.\n\n## Affected lots\nGTIN 00811311021062,  Lot Numbers:  305737, 305738, 305913, 305929, 305940, 306079, 306085, 306093, 306097, 306115, 306168, 306178, 306187, 306195, 306200, 306207, 306219, 306232, 306242, 306244, 306272, 306279, 306290, 306305, 306311, 306319, 306320, 306328, 306338, 306348, 306359, 306372, 306391, 306408, 306420, 306431, 306440, 306453, 306460, 306473, 306478, 306508, 306523, 306546, 306555, 306568, 306579, 306589, 306626, 306636, 306645, 306662, 306691, 306713, 306731, 306745, 306754, 306776, 306787, 306795, 306806, 306834, 306862, 306867, 306871, 306876, 306894, 306896, 306905, 306913, 306921, 306935, 306950, 306956, 306963, 306978, 306989, 307005, 307009, 307036, 307040, 307048, 307066, 307091, 307101, 307111, 307113, 307124, 307138, 307148, 307157, 307174, 307185, 307195, 307207, 307215, 307226, 307236, 307246, 307256, 307259, 307265, 307282, 307285, 307299, 307304, 307311, 307321, 307346, 307351, 307354, 307355, 307356, 307357, 307358, 307361, 305736-2.\n\n## Distribution\nWorldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica"}