Abiomed, Inc.
Abiomed, Inc. holds FDA 510(k) medical device clearances, first cleared 1989, most recent 2025, with 78 FDA device recalls on record.
Top product codes for Abiomed, Inc.
FDA recalls by Abiomed, Inc.
10 most recent of 78- Z-2682-2026 — ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
- Z-2685-2026 — ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
- Z-2683-2026 — ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
- Z-2692-2026 — ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
- Z-2689-2026 — ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
- Z-2686-2026 — ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
- Z-2688-2026 — ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
- Z-2681-2026 — ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
- Z-2691-2026 — ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
- Z-2687-2026 — ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Abiomed, Inc.
- K252766 — 14Fr Low Profile Introducer Kit
- K241708 — Abiomed 14Fr Low Profile Introducer Kit
- K221294 — preCARDIA Occlusion System
- K223161 — OXY-1 System
- K222113 — Abiomed 14Fr Low Profile Introducer Set
- K202330 — Impella XR Sheath Set
- K200109 — OXY-1 System
- K201116 — Abiomed 23 Fr Sheath
- K192769 — Impella CP Introducer
- K112892 — IMPELLA 2.5 PLUS CATHETER
- K110845 — IMPELLA CONTROLLER WITH FLOW CONTROL
- K093801 — IMPELLA CONTROLLER
- K083111 — IMPELLA 5.0 CATHETER FAMILY
- K063723 — IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
- K070225 — SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
- K062582 — SUPRACOR BALLOON CATHETER
- K911643 — ABIODENT PERIOTEMP(R) SYSTEM
- K900574 — ABIOMED BODY LEAD ANALYZER MODEL 200/20
- K885075 — ABIOMED PERIOTEMP(TM) PROBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.