{"url_path":"/fda/device/recalls/Z-2602-2026","section_key":"summary","section_title":"DEVICE Recall: Abiomed, Inc. — Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-22","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2602-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Abiomed, Inc."},"word_count":105,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2602-2026\n\n**Recalling firm:** Abiomed, Inc.\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-22\n**Report date:** 2026-07-01\n\n## Product\nAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.\n\n## Reason\nPotential for thrombus formation during prolonged use of the introducer.\n\n## Affected lots\nImpella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530.   Introducer Product Code: 1000542; Batch Number: 2041530.\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan."}