Recall archive
25 recalls · page 1 of 2
Reported Jul 22, 2026
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand · Product · Product details — A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2026
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand · Product · Product details — Potential for thrombus formation during prolonged use of the introducer.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2026
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand · Reason for recall — A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 8, 2026
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — Increased risk of purge leaks with Generation 1 purge cassettes.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 11, 2026
Impella RP with SmartAssist. Product Code: 0046-0035.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
Matched: Brand — Device packaged in incorrect outer box carton.
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
FDA (openFDA device enforcement)
Reported Oct 15, 2025
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased…
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Impella RP with SmartAssist; Product Number: 0046-0035;
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand · Reason for recall — Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
Matched: Brand · Reason for recall — A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently…
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2024
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — Nine (9) Impella CP pumps failed inspection and were inadvertently released.
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
Matched: Brand — Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in…
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
Matched: Brand · Product · Product details — 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…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 10, 2024
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
Matched: Brand — The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness:…
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
Matched: Brand — Pump not detected as connected to controller due to software issue.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling…
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2023
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported May 24, 2023
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
FDA (openFDA device enforcement)
Reported Feb 9, 2022
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a…
FDA (openFDA device enforcement)
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