Abiomed, Inc.
Medical device manufacturer in Danvers, MA.
19510(k) clearances
2PMA approvals
89recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252766 | 14Fr Low Profile Introducer KitDYB · Special | 10/08/2025SE |
| K241708 | Abiomed 14Fr Low Profile Introducer KitDYB · Traditional | 08/06/2024SE |
| K221294 | preCARDIA Occlusion SystemMJN · Traditional | 06/30/2023SESU |
| K223161 | OXY-1 SystemDTZ · Traditional | 02/23/2023SE |
| K222113 | Abiomed 14Fr Low Profile Introducer SetDYB · Traditional | 10/13/2022SE |
| K202330 | Impella XR Sheath SetDYB · Traditional | 12/07/2020SE |
| K200109 | OXY-1 SystemDTZ · Traditional | 10/23/2020SE |
| K201116 | Abiomed 23 Fr SheathDYB · Traditional | 06/15/2020SE |
| K192769 | Impella CP IntroducerDYB · Traditional | 11/18/2019SE |
| K112892 | Impella 2.5 Plus CatheterPBL · Special | 09/06/2012SESU |
| K110845 | Impella Controller with Flow ControlKFM · Special | 04/27/2011SE |
| K093801 | Impella ControllerKFM · Traditional | 07/08/2010SE |
| K083111 | Impella 5.0 Catheter FamilyKFM · Traditional | 04/16/2009SE |
| K063723 | Impella Recover LP 2.5 Percutaneous Cardiac Support SystemKFM · Traditional | 05/30/2008SE |
| K070225 | Supracor Intr-Aortic Balloon Pump ConsoleDSP · Traditional | 12/13/2007SE |
| K062582 | Supracor Balloon CatheterDSP · Traditional | 12/14/2006SE |
| K911643 | Abiodent Periotemp(R) SystemEIL · Traditional | 07/09/1991SE |
| K900574 | Abiomed Body Lead Analyzer Model 200/20JAO · Traditional | 03/15/1990SE |
| K885075 | Abiomed Periotemp(Tm) ProbeEIL · Traditional | 02/13/1989SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3150-2026 | Impella Optical Controller, Automated Impella Controller, Impella Connect Package with…The potential for purge cassette recognition issues due to the failure of the purge flag component of the… | 08/12/2026Open, Classified |
| Z-3149-2026 | Impella Optical Controller with the below product descriptions and corresponding Product…The potential for purge cassette recognition issues due to the failure of the purge flag component of the… | 08/12/2026Open, Classified |
| Z-3148-2026 | Automated Impella Controller (AIC) with the below product descriptions and corresponding…The potential for purge cassette recognition issues due to the failure of the purge flag component of the… | 08/12/2026Open, Classified |
| Z-2693-2026 Class I | ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2692-2026 Class I | ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2691-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2690-2026 Class I | ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2689-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2688-2026 Class I | ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2687-2026 Class I | ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2686-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2685-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2684-2026 Class I | ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2683-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2682-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2681-2026 Class I | ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2602-2026 Class I | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…Potential for thrombus formation during prolonged use of the introducer. | 05/22/2026Open, Classified |
| Z-2601-2026 Class I | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…Potential for thrombus formation during prolonged use of the introducer. | 05/22/2026Open, Classified |
| Z-2600-2026 Class I | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product…Potential for thrombus formation during prolonged use of the introducer. | 05/22/2026Open, Classified |
| Z-2599-2026 Class I | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product…Potential for thrombus formation during prolonged use of the introducer. | 05/22/2026Open, Classified |
| Z-2457-2026 Class I | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in… | 05/18/2026Open, Classified |
| Z-2360-2026 Class I | Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled…Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left… | 05/14/2026Open, Classified |
| Z-2211-2026 Class I | Automated Impella Controller (AIC); Product Code: 0042-0000-US;A retrospective review identified that there are AIC units requiring specific hardware updates to address… | 04/20/2026Open, Classified |
| Z-1589-2026 Class I | Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and…Increased risk of purge leaks with Generation 1 purge cassettes. | 02/18/2026Open, Classified |
| Z-1591-2026 Class I | Automated Impella Controller (AIC), labeled as the following with corresponding Product…Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be… | 02/16/2026Open, Classified |
| Z-1471-2026 Class I | Impella RP. Product Code: 0046-0011.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | 01/27/2026Open, Classified |
| Z-1470-2026 Class I | Impella RP Flex with SmartAssist. Product Code: 1000323.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | 01/27/2026Open, Classified |
| Z-1469-2026 Class I | Impella RP with SmartAssist. Product Code: 0046-0035.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | 01/27/2026Open, Classified |
| Z-1030-2026 Class II | Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.Device packaged in incorrect outer box carton. | 12/04/2025Open, Classified |
| Z-0069-2026 Class I | Automated Impella Controller (AIC), used for left heart support blood pump, labeled as…Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller… | 10/01/2025Open, Classified |
| Z-0136-2026 Class I | Automated Impella Controller (AIC) labeled as the following with corresponding Product…Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. | 09/16/2025Open, Classified |
| Z-2568-2025 Class I | Automated Impella Controller (AIC) with the below brands and product codes. Used with…Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current… | 08/20/2025Open, Classified |
| Z-2164-2025 Class I | Automated Impella Controller (AIC), used in left heart support blood pump, including the…A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is… | 06/23/2025Open, Classified |
| Z-0830-2025 Class I | Impella RP Flex with SmartAssist; Product Number: 1000323;Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting… | 12/12/2024Open, Classified |
| Z-0829-2025 Class I | Impella RP with SmartAssist; Product Number: 0046-0035;Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting… | 12/12/2024Open, Classified |
| Z-2971-2024 Class II | Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2970-2024 Class II | Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2969-2024 Class II | Impella CP Smart Assist Set; Product Code: 1000402;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2968-2024 Class II | Impella 5.5 Set AU; Product Code: 1000361;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2967-2024 Class II | ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2966-2024 Class II | Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2965-2024 Class II | Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2964-2024 Class II | Pump 381 Pump Set (US); Product Code: 1000080;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2963-2024 Class II | Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2962-2024 Class II | Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2961-2024 Class II | Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2960-2024 Class II | Impella CP Smart Assist Set APAC; Product Code: 0048-0047;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2959-2024 Class II | Pump 371 14F LT CMR Set; Product Code: 0048-0045;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2958-2024 Class II | Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2957-2024 Class II | Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2956-2024 Class II | Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2955-2024 Class II | Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2954-2024 Class II | Impella CP Smart Assist Set, EU; Product Code: 0048-0014;A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps… | 08/05/2024Open, Classified |
| Z-2319-2024 Class I | Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support…Nine (9) Impella CP pumps failed inspection and were inadvertently released. | 05/31/2024Open, Classified |
| Z-1074-2024 Class II | Impella catheters - Intravascular micro axial blood pumps that support a patient's…New warnings are being added to the Instructions for Use for all affected products to reduce the possibility… | 12/27/2023Open, Classified |
| Z-0980-2024 Class I | Impella catheters - Intravascular micro axial blood pumps that support a patient's…IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall… | 12/27/2023Open, Classified |
| Z-0636-2024 Class II | Impella Connect, software portal for online device management that allows clinicians and…The following features have been disabled from the web-based portal because the FDA has not evaluated these… | 12/06/2023Open, Classified |
| Z-0655-2024 Class II | Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0654-2024 Class II | Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0653-2024 Class II | Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0652-2024 Class II | Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0651-2024 Class II | Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0650-2024 Class II | Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0649-2024 Class II | Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0648-2024 Class II | Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0647-2024 Class II | Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0646-2024 Class II | Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of…Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile… | 11/07/2023Open, Classified |
| Z-0441-2024 Class II | Automated Impella Controller (AIC), product number 0042-040-US with software versions…Pump not detected as connected to controller due to software issue. | 10/10/2023Terminated |
| Z-0440-2024 Class II | Automated Impella Controller (AIC), product number 0042-000-US with software versions…Pump not detected as connected to controller due to software issue. | 10/10/2023Terminated |
| Z-2281-2023 Class I | Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number…A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus… | 06/29/2023Open, Classified |
| Z-2116-2023 Class I | Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers…There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent… | 06/14/2023Open, Classified |
| Z-2115-2023 Class I | Impella CP intravascular micro axial blood pump, Product Number 0048-0032There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent… | 06/14/2023Open, Classified |
| Z-2114-2023 Class I | Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers…There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent… | 06/14/2023Open, Classified |
| Z-2113-2023 Class I | Impella LD intravascular micro axial blood pump, Product Number 005082There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent… | 06/14/2023Open, Classified |
| Z-2112-2023 Class I | Impella 5.0 intravascular micro axial blood pump, Product Number 005062There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent… | 06/14/2023Open, Classified |
| Z-2111-2023 Class I | Impella 2.5 intravascular micro axial blood pump, Product Number 005042There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent… | 06/14/2023Open, Classified |
| Z-2128-2023 Class II | Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms… | 05/26/2023Open, Classified |
| Z-1590-2023 Class I | Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that…The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. | 04/17/2023Open, Classified |
| Z-0550-2022 Class I | OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1…The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use… | 12/14/2021Terminated |
| Z-1175-2024 Class II | Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US…Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update… | 03/01/2021Terminated |
| Z-0345-2020 Class II | lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump…This one pump shipped with incorrect pump programming, the initial production working version of the… | 09/04/2019Terminated |
| Z-3251-2026 | Automated Impella Controller (AIC) with the below product descriptions and corresponding…Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical… | 02/19/2019Open, Classified |
| Z-2238-2026 Class I | Automated Impella Controller (AIC) with the below product descriptions and corresponding…Retrospective submission for following issues identified: 1. Alarm failures, power-path faults… | 01/17/2011Open, Classified |
| Z-2382-2010 | Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is…Pump may separate at the motor housing while device is explanted | 07/05/2010Terminated |
| Z-0824-2010 | Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by…Console shut down with no audible alarm | 12/16/2009Terminated |
| Z-1914-2009 | Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a…The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific… | 05/08/2009Terminated |
| Z-1931-2009 | iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is…iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient… | 04/23/2009Terminated |
| Z-2304-2008 | Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD…Subassembly incorrectly aligned | 06/13/2008Terminated |
| Z-0574-2007 | AB5000 Console Circulatory Support System Catalog Number: 0015-0000Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source. | 01/08/2007Terminated |