Data / Medical devices / United States / Abiomed, Inc.
Abiomed, Inc.: FDA-registered device maker in Danvers, MA, United States, 5 510(k) clearances and 2 PMA approvals
Abiomed, Inc. is registered with the FDA (registration 1220648) in Danvers, MA, United States. It lists 10 device types. The FDA files 5 510(k) clearances and 2 PMA approvals under its listings, the newest dated February 23, 2023. 39 recall events name it as the recalling firm (21 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1220648
- Address
- 22 Cherry Hill Dr, Danvers, MA, United States, 01923
- Owner or operator
- ABIOMED, INC. (1220648)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 15, 2014
- Registered through
- 2026
- Brand names listed
- Abiomed 14Fr Low Profile Introducer Set, Abiomed 23 Fr Introducer, Automated Impella Controller (AIC), Impella 2.5, Impella 5, Impella 5.5 with SmartAssist, Impella CP, Impella CP Introducer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Complaint file establishment | accessdata.fda.gov |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | 2 | Complaint file establishment | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Oxygenator, Cardiopulmonary Bypass | DTZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | 2 | Complaint file establishment | accessdata.fda.gov |
| Temporary Non-Roller Type Left Heart Support Blood Pump | OZD | 3 | Manufacturer | accessdata.fda.gov |
| Temporary Non-Roller Type Right Heart Support Blood Pump | PYX | 3 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2023 | K223161 | OXY-1 System | DTZ | Substantially Equivalent | Abiomed, Inc. | accessdata.fda.gov |
| January 19, 2023 | K223872 | Low Profile Companion Sheath | DYB | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| October 13, 2022 | K222113 | Abiomed 14Fr Low Profile Introducer Set | DYB | Substantially Equivalent | Abiomed, Inc. | accessdata.fda.gov |
| June 15, 2020 | K201116 | Abiomed 23 Fr Sheath | DYB | Substantially Equivalent | Abiomed, Inc. | accessdata.fda.gov |
| November 18, 2019 | K192769 | Impella CP Introducer | DYB | Substantially Equivalent | Abiomed, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 20, 2017 | P170011 | Impella RP System | PYX | 61 | April 1, 2026 | accessdata.fda.gov |
| March 23, 2015 | P140003 | IMPELLA 2.5 System | OZD | 127 | June 15, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 18, 2026 | 99778 | Not yet classified | Open, Classified | Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump. | Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) | accessdata.fda.gov |
| August 12, 2026 | 99671 | Class I | Ongoing | 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: | The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. | accessdata.fda.gov |
| June 11, 2026 | 98893 | Class I | Ongoing | 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 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | accessdata.fda.gov |
| May 22, 2026 | 99002 | Class I | Ongoing | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434. | Potential for thrombus formation during prolonged use of the introducer. | accessdata.fda.gov |
| May 18, 2026 | 98946 | Class I | Ongoing | 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 some cases, interruption or loss of mechanical circulatory support. | accessdata.fda.gov |
| May 14, 2026 | 98853 | Class I | Ongoing | 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: 0042-0000-AU. 2. Impella Contr | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. | accessdata.fda.gov |
| April 20, 2026 | 98770 | Class I | Ongoing | Automated Impella Controller (AIC); Product Code: 0042-0000-US | A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to th | accessdata.fda.gov |
| February 18, 2026 | 98395 | Class I | Ongoing | 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: 0043-0003. 2. Impella | Increased risk of purge leaks with Generation 1 purge cassettes. | accessdata.fda.gov |
| February 16, 2026 | 98393 | Class I | Ongoing | 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; Product Code: 0042-0000 | Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps. | accessdata.fda.gov |
| January 27, 2026 | 98276 | Class I | Ongoing | Impella RP with SmartAssist. Product Code: 0046-0035. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | accessdata.fda.gov |
| December 4, 2025 | 98086 | Class II | Ongoing | Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU. | Device packaged in incorrect outer box carton. | accessdata.fda.gov |
| October 1, 2025 | 97617 | Class I | Ongoing | 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. 2. Impella Controlle | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). | accessdata.fda.gov |
| September 16, 2025 | 97513 | Class I | Ongoing | 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, Product Code: 1000201. 3 | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. | accessdata.fda.gov |
| August 20, 2025 | 97440 | Class I | Ongoing | 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, Packaged, US, Loaner; Produ | Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm. | accessdata.fda.gov |
| June 23, 2025 | 97078 | Class I | Ongoing | 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, CA; Product Code: 0042 | A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected | accessdata.fda.gov |
| December 12, 2024 | 95780 | Class I | Ongoing | Impella RP with SmartAssist; Product Number: 0046-0035 | Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interactio | accessdata.fda.gov |
| August 5, 2024 | 95129 | Class II | Ongoing | 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 during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction. | accessdata.fda.gov |
| May 31, 2024 | 94833 | Class I | Ongoing | Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump | Nine (9) Impella CP pumps failed inspection and were inadvertently released. | accessdata.fda.gov |
| December 27, 2023 | 93749 | Class I | Ongoing | Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) P | IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling. | accessdata.fda.gov |
| December 27, 2023 | 93746 | Class II | Ongoing | Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) P | New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device. | accessdata.fda.gov |
| December 6, 2023 | 93581 | Class II | Ongoing | Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data. | The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature | accessdata.fda.gov |
| November 7, 2023 | 93501 | Class II | Ongoing | Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 10 | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis | accessdata.fda.gov |
| October 10, 2023 | 93406 | Class II | Terminated | Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1. | Pump not detected as connected to controller due to software issue. | accessdata.fda.gov |
| June 29, 2023 | 92411 | Class I | Ongoing | Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323 | A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis | accessdata.fda.gov |
| June 14, 2023 | 92321 | Class I | Ongoing | Impella 2.5 intravascular micro axial blood pump, Product Number 005042 | There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility. | accessdata.fda.gov |
| May 26, 2023 | 92521 | Class II | Ongoing | Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 | There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach. | accessdata.fda.gov |
| April 17, 2023 | 91955 | Class I | Ongoing | Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 | The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. | accessdata.fda.gov |
| December 14, 2021 | 89328 | Class I | Terminated | OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separ | The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia. | accessdata.fda.gov |
| March 1, 2021 | 93876 | Class II | Terminated | Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular) | Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC. | accessdata.fda.gov |
| September 4, 2019 | 84025 | Class II | Terminated | lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI | This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled. | accessdata.fda.gov |
| February 19, 2019 | 99747 | Class II | Ongoing | 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: | Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconne | accessdata.fda.gov |
| January 17, 2011 | 98868 | Class I | Ongoing | 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: | Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to com | accessdata.fda.gov |
| July 5, 2010 | 56315 | Not yet classified | Terminated | Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours | Pump may separate at the motor housing while device is explanted | accessdata.fda.gov |
| December 16, 2009 | 54167 | Not yet classified | Terminated | Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intended to provide complete short-term support of the left and/or right sides of the heart to patients suf | Console shut down with no audible alarm | accessdata.fda.gov |
| May 8, 2009 | 52168 | Not yet classified | Terminated | Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used | The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition. | accessdata.fda.gov |
| April 23, 2009 | 52200 | Not yet classified | Terminated | iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPu | iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation. | accessdata.fda.gov |
| June 13, 2008 | 48724 | Not yet classified | Terminated | Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart. | Subassembly incorrectly aligned | accessdata.fda.gov |
| January 8, 2007 | 37170 | Not yet classified | Terminated | AB5000 Console Circulatory Support System Catalog Number: 0015-0000 | Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source. | accessdata.fda.gov |
| August 19, 2003 | 27071 | Not yet classified | Terminated | BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000 | Bi-Ventricular support system may switch to battery when primary voltage (AC) is available | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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- All makers of Control, Pump Speed, Cardiopulmonary Bypass
- All makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- All makers of Introducer, Catheter
Updated October 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.