{"url_path":"/fda/device/recalls/Z-2807-2026","section_key":"summary","section_title":"DEVICE Recall: Medtronic Perfusion Systems — EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-24","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2807-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medtronic Perfusion Systems"},"word_count":120,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2807-2026\n\n**Recalling firm:** Medtronic Perfusion Systems\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-24\n**Report date:** 2026-08-05\n\n## Product\nEOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522\n\n## Reason\nPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.\n\n## Affected lots\nUDI-DI: 00199150023288, Lot Numbers: 0233286436; UDI-DI: 20199150023282, Lot Numbers: 0232709428 0232744924 0232745061 0232745092 0232798556 0232862763 0232862778 0232862794 0232862798 0232903216 0232903291 0232903383 0232990983 0233286318 0233286414 0233286436 0233427120 0233528730 0233553623 0233556386 0233585113 0233585114 0232670802\n\n## Distribution\nWorldwide - US Nationwide distribution."}