Abiomed recalls
30 official recalls and safety alerts involving Abiomed since 2022-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Abiomed or the relevant agency.
- 2026-09-30
USAbiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
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…
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide and the countries of Austria, Belgium, Canada,…Official notice →- 2026-09-23
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
FDA · DeviceAbiomed, Inc.Domestic: Nationwide Distribution. International: United Arab Emirates,…Official notice → - 2026-07-22
- US
Abiomed, Inc. recalls ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart…
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…
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium…Official notice → - 2026-07-01
- US
Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413,…
Potential for thrombus formation during prolonged use of the introducer.
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA…Official notice → - 2026-06-24
- US
Abiomed, Inc. recalls 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.
FDA · DeviceAbiomed, Inc.US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to…Official notice → - US
Abiomed, Inc. recalls Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes:…
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2026-06-03
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
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…
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Denmark,…Official notice → - US
Abiomed, Inc. recalls 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;…
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA,…Official notice → - 2026-04-08
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA;…
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.
FDA · DeviceAbiomed, Inc.International distribution in the country of Australia, Canada, France,…Official notice → - US
Abiomed, Inc. recalls Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and…
Increased risk of purge leaks with Generation 1 purge cassettes.
- 2026-03-11
- US
Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Canada,…Official notice → - 2026-01-14
- US
Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
FDA · DeviceAbiomed, Inc.International distribution to the country of Australia and Taiwan.Official notice → - 2025-10-29
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product…
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil,…Official notice → - 2025-10-15
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1.…
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
FDA · DeviceAbiomed, Inc.Nationwide distribution. International distribution to United Arab Emirates,…Official notice → - 2025-10-01
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged,…
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…
FDA · DeviceAbiomed, Inc.US distribution to AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH,…Official notice → - 2025-08-06
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU;…
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei…Official notice → - 2025-01-22
- US
Abiomed, Inc. recalls Impella RP Flex with SmartAssist; Product Number: 1000323;
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…
- 2024-09-11
- US
Abiomed, Inc. recalls ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
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…
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-07-24
- US
Abiomed, Inc. recalls 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.
- 2024-02-28
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems…
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.
- 2024-02-21
- US
Abiomed, Inc. recalls Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella…
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.
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR,…Official notice → - US
Abiomed, Inc. recalls Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella…
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.
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR,…Official notice → - 2024-01-17
- US
Abiomed, Inc. recalls Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for…
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…
FDA · DeviceAbiomed, Inc.Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX…Official notice → - 2024-01-10
- US
Abiomed, Inc. recalls Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella…
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 email feature; AIC alarm color on case tile feature;…
- 2023-12-13
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Pump not detected as connected to controller due to software issue.
- 2023-08-09
- US
Abiomed, Inc. recalls 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…
FDA · DeviceAbiomed, Inc.US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA,…Official notice → - 2023-07-26
- US
Abiomed, Inc. recalls Impella LD intravascular micro axial blood pump, Product Number 005082
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…
- 2023-07-19
- US
Abiomed, Inc. recalls 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…
- 2023-05-24
- US
Abiomed, Inc. recalls Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product…
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
FDA · DeviceAbiomed, Inc.US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland,…Official notice → - 2022-02-09
- US
Abiomed, Inc. recalls OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and…
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…