Company ยท US
Abiomed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2025. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
93recalls (34 in 12 months)
27recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | 50 |
| DYB | Introducer, Catheter | 34 |
| PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | 7 |
| DSQ | Ventricular (Assist) Bypass | 5 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 5 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 3 |
| DSP | System, Balloon, Intra-Aortic And Control | 2 |
| EIL | Gauge, Depth, Instrument, Dental | 2 |
| JAO | Scanner, Fluorescent | 1 |
| LOZ | Artificial Heart | 1 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 |
| PBL | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2025 | K252766 | 14Fr Low Profile Introducer Kit Abiomed, Inc. | DYB |
| Aug 6, 2024 | K241708 | Abiomed 14Fr Low Profile Introducer Kit Abiomed, Inc. | DYB |
| Jun 30, 2023 | K221294 | preCARDIA Occlusion System Abiomed, Inc. | MJN |
| Feb 23, 2023 | K223161 | OXY-1 System Abiomed, Inc. | DTZ |
| Oct 13, 2022 | K222113 | Abiomed 14Fr Low Profile Introducer Set Abiomed, Inc. | DYB |
| Dec 7, 2020 | K202330 | Impella XR Sheath Set Abiomed, Inc. | DYB |
| Oct 23, 2020 | K200109 | OXY-1 System Abiomed, Inc. | DTZ |
| Jun 15, 2020 | K201116 | Abiomed 23 Fr Sheath Abiomed, Inc. | DYB |
| Nov 18, 2019 | K192769 | Impella CP Introducer Abiomed, Inc. | DYB |
| Sep 6, 2012 | K112892 | IMPELLA 2.5 PLUS CATHETER Abiomed, Inc. | PBL |
| Apr 27, 2011 | K110845 | IMPELLA CONTROLLER WITH FLOW CONTROL Abiomed, Inc. | KFM |
| Jul 8, 2010 | K093801 | IMPELLA CONTROLLER Abiomed, Inc. | KFM |
| Apr 16, 2009 | K083111 | IMPELLA 5.0 CATHETER FAMILY Abiomed, Inc. | KFM |
| May 30, 2008 | K063723 | IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM Abiomed, Inc. | KFM |
| Dec 13, 2007 | K070225 | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE Abiomed, Inc. | DSP |
| Dec 14, 2006 | K062582 | SUPRACOR BALLOON CATHETER Abiomed, Inc. | DSP |
| Jul 9, 1991 | K911643 | ABIODENT PERIOTEMP(R) SYSTEM Abiomed, Inc. | EIL |
| Mar 15, 1990 | K900574 | ABIOMED BODY LEAD ANALYZER MODEL 200/20 Abiomed, Inc. | JAO |
| Feb 13, 1989 | K885075 | ABIOMED PERIOTEMP(TM) PROBE Abiomed, Inc. | EIL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2026 | Abiomed, Inc. Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump. Open, Classified |
OZD | None listed |
| Oct 28, 2026 | Abiomed, Inc. Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump. Open, Classified |
OZD | None listed |
| Oct 28, 2026 | Abiomed, Inc. Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump. Open, Classified |
OZD | None listed |
| Sep 21, 2026 | Abiomed, Inc. 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, Pack Open, Classified |
OZD | None listed |
| Sep 16, 2026 | Abiomed, Inc. 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; P Open, Classified |
OZD | None listed |
| Sep 16, 2026 | Abiomed, Inc. 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, Open, Classified |
OZD | None listed |
| Sep 16, 2026 | Abiomed, Inc. 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 Open, Classified |
OZD | None listed |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. 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 Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. 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 Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. 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 Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. 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 Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. 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 Open, Classified |
DYB | K192769 K201116 |
| Jun 25, 2026 | 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. Open, Classified |
DYB | K241708 |
| Jun 25, 2026 | Abiomed, Inc. Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834. Open, Classified |
DYB | K241708 |
| Jun 25, 2026 | Abiomed, Inc. Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435. Open, Classified |
DYB | K241708 |
| Jun 25, 2026 | Abiomed, Inc. Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434. Open, Classified |
DYB | K241708 |
| Jun 18, 2026 | Abiomed, Inc. Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. Open, Classified |
OZD | None listed |
| Jun 12, 2026 | Abiomed, Inc. Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes:
1. Impella Controller, Packaged, AU; Product Code: 0042-00 Open, Classified |
OZD | None listed |
| May 28, 2026 | Abiomed, Inc. 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, Packa Open, Classified |
OZD | None listed |
| May 22, 2026 | Abiomed, Inc. Automated Impella Controller (AIC);
Product Code: 0042-0000-US; Open, Classified |
OZD | None listed |
| Mar 31, 2026 | Abiomed, Inc. Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes.
1. Purge Cassette, 5 Pack; Product Code: Open, Classified |
OZD | None listed |
| Mar 27, 2026 | Abiomed, Inc. Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes:
1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.
2. Impella Controller, Packaged, EU; Open, Classified |
OZD | None listed |
| Feb 27, 2026 | Abiomed, Inc. Impella RP. Product Code: 0046-0011. Open, Classified |
PYX | None listed |
| Feb 27, 2026 | Abiomed, Inc. Impella RP Flex with SmartAssist. Product Code: 1000323. Open, Classified |
PYX | None listed |
| Feb 27, 2026 | Abiomed, Inc. Impella RP with SmartAssist. Product Code: 0046-0035. Open, Classified |
PYX | None listed |
| Jan 8, 2026 | Abiomed, Inc. Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU. Open, Classified |
OZD | None listed |
| Oct 17, 2025 | Abiomed, Inc. Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes:
1. AIC w/Impella Connect for ECP, Product Code: 1000432.
2. Dbl optical, AIC Impella Connect, Phg US, Pr Open, Classified |
OZD | None listed |
| Oct 9, 2025 | Abiomed, Inc. Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes:
1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. Open, Classified |
OZD | None listed |
| Sep 19, 2025 | Abiomed, Inc. Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump.
1. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
2. Impella Controller, Pack Open, Classified |
OZD | None listed |
| Jul 26, 2025 | Abiomed, Inc. Automated Impella Controller (AIC), used in left heart support blood pump, including the following:
1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU.
2. Impella Controller, Packaged Open, Classified |
OZD | None listed |
| Jan 15, 2025 | Abiomed, Inc. Impella RP Flex with SmartAssist; Product Number: 1000323; Open, Classified |
PYX | None listed |
| Jan 15, 2025 | Abiomed, Inc. Impella RP with SmartAssist; Product Number: 0046-0035; Open, Classified |
PYX | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella CP Smart Assist Set; Product Code: 1000402; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 Set AU; Product Code: 1000361; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Pump 381 Pump Set (US); Product Code: 1000080; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; Open, Classified |
OZD | None listed |
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