Abiomed, Inc.
Abiomed, Inc. holds FDA 510(k) medical device clearances, first cleared 1989, most recent 2025, with 84 FDA device recalls on record.
Top product codes for Abiomed, Inc.
FDA recalls by Abiomed, Inc.
10 most recent of 84- Z-0208-2027 — Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
- Z-0209-2027 — Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
- Z-0210-2027 — Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
- Z-3148-2026 — Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
- Z-3149-2026 — Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.
- Z-3150-2026 — Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;
- 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
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.