Abiomed, Inc. recalls
Every recall we track for Abiomed, Inc. — 81 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them. 6 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Abiomed, Inc. fell by more than half in 2025 (5, down from 21 in 2024). 7% rated “stop using now”.
All FDA recall records for Abiomed, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 1 | 0 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 1 | 0 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 6 | 14 | 3 | 1 | 24 |
| 2024 | 0 | 2 | 17 | 2 | 21 |
| 2025 | 0 | 1 | 2 | 2 | 5 |
| 2026 (to date) | 0 | 5 | 23 | 0 | 28 |
Most common reasons for Abiomed, Inc. recalls
What to do if you have a recalled Abiomed, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Abiomed, Inc. recalls
29 shown- Lower riskMedical device
Abiomed, Inc. recalls Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions
Abiomed recalls Impella Optical Controller, Automated Impella Controller, and Impella Connect Package units with specific product codes and serial numbers due to potential purge cassette recognition issues from purge flag component failure.
AbiomedAug 12, 2026 - Lower riskMedical device
Abiomed, Inc. recalls ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product
Abiomed recalls Impella CP Set (Code 0048-0003) due to potential introducer sheath leakage. This risk may cause complications during heart pump procedures. Affected units include specific model sizes.
AbiomedJun 11, 2026 - Lower riskMedical device
Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product
Abiomed recalls 10th Gen Impella CP Set with SmartAssist containing affected 14Fr Low Profile Introducer Kits due to potential blood clot formation during long-term use. Product codes and serial numbers listed for identification.
AbiomedMay 22, 2026 - Use cautionMedical device
Abiomed, Inc. recalls Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Abiomed recalls Impella CP Set with SmartAssist (product codes 1000080, 1000851, 0048-0014, 0048-0024-JP) due to potential persistent low purge pressure alarms and interruption of mechanical circulatory support.
AbiomedMay 18, 2026 - Lower riskMedical device
Abiomed, Inc. recalls Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with
Abiomed is a leading medical device manufacturer specializing in cardiovascular and surgical products. We provide innovative solutions for healthcare professionals.
AbiomedMay 14, 2026 - Use cautionMedical device
Abiomed, Inc. recalls Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Abiomed recalls Automated Impella Controller units without recent hardware updates to prevent potential motor control interruptions, startup failures, and console boot-up issues.
AbiomedApr 20, 2026 - Lower riskMedical device
Abiomed, Inc. recalls Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below
Abiomed is a leading manufacturer of medical devices and equipment, specializing in cardiovascular and vascular products. Their products include heart valves, catheters, and other critical medical devices.
AbiomedFeb 18, 2026 - Lower riskMedical device
Abiomed, Inc. recalls Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller,
Abiomed recalls Automated Impella Controllers with software versions 8.2.2-8.5 that may delay 'Purge System Blocked' alarms when used with first-gen Impella 5.5 pumps. Affected units include specific product codes and serial numbers.
AbiomedFeb 16, 2026 - Lower riskMedical device
Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Abiomed recalls Impella RP Flex with SmartAssist (Product Code 1000323) due to potential sensor drift causing inaccurate readings. Affected units may require monitoring or repair.
AbiomedJan 27, 2026 - Lower riskMedical device
Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Abiomed recalls Impella 5.5 with SmartAssist S2 devices due to incorrect outer packaging. Affected units have specific serial numbers and Australian configuration codes. No action is required as the packaging error does not affect safety.
AbiomedDec 4, 2025 - UnratedMedical device
Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding
Abiomed recalls Automated Impella Controllers (AIC) due to potential cybersecurity vulnerabilities in the operating system. Affected models include various international versions with specific product codes and serial numbers.
AbiomedOct 1, 2025 - Lower riskMedical device
Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect
Abiomed is a leading manufacturer of medical devices, specializing in cardiovascular and surgical equipment. Their products include heart valves, catheters, and surgical instruments.
AbiomedSep 16, 2025 - Use cautionMedical device
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella
Abiomed recalls specific Impella Controllers that may cause pump stoppage or failure alarms when used with heart assist pumps. Affected units have unique product codes and serial numbers.
AbiomedAug 20, 2025 - UnratedMedical device
Abiomed, Inc. recalls Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella
Abiomed recalls Automated Impella Controllers (AIC) used in left heart support pumps due to potential failure to detect connected pumps. Affected models include various international versions with specific product codes and serial numbers. No remedy is listed in the recall notice.
AbiomedJun 23, 2025 - Use cautionMedical device
Abiomed, Inc. recalls Impella RP Flex with SmartAssist; Product Number: 1000323;
Abiomed recalls Impella RP Flex with SmartAssist pumps with serial numbers listed. Optical sensors may be damaged during insertion or manipulation of guidewires or central venous lines, causing temporary or permanent pump stop. Check your pump's serial number against the list.
AbiomedDec 12, 2024 - Lower riskMedical device
Abiomed, Inc. recalls ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Abiomed recalls ImpellaCP SmartAssistSetAPAC models with potential device interaction during coronary interventions. No immediate action needed but updated instructions will address the risk.
AbiomedAug 5, 2024 - UnratedMedical device
Abiomed, Inc. recalls Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Abiomed recalls 9 Impella CP SmartAssist blood pumps (Product No. 1000080) that failed inspection. These pumps may have been released without proper safety checks.
AbiomedMay 31, 2024 - Use cautionMedical device
Abiomed, Inc. recalls Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code
Abiomed recalls Impella 2.5, 5.0, 5.5 and other catheters due to potential left ventricle perforation from improper handling. Affected units include specific product codes and sets. No action needed if device is properly used.
AbiomedDec 27, 2023 - Lower riskMedical device
Abiomed, Inc. recalls Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code
Abiomed recalls Impella catheters (2.5, 5.0, LD, RP, CP models) due to updated warnings to reduce fiber risk that could cause low blood flow. All affected products have new instructions.
AbiomedDec 27, 2023 - Use cautionMedical device
Abiomed, Inc. recalls Impella Connect, software portal for online device management that allows clinicians and Impella support staff to
Abiomed recalls Impella Connect software portal version 1.1-3.17.1 due to disabled safety features. Users may face risks from unmonitored device alerts.
AbiomedDec 6, 2023 - Use cautionMedical device
Abiomed, Inc. recalls Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are
Abiomed recalls 14Fr Introducer Kits with potential sterile barrier holes that could cause infections. Affected kits may expose patients to microorganisms, leading to sepsis or bacteremia. Contact Abiomed for details.
AbiomedNov 7, 2023 - Lower riskMedical device
Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Abiomed recalls Automated Impella Controller (AIC) models with software versions V8.4 and V8.4.1 due to pump connection detection failure. Affected units may not properly detect the pump, risking improper operation.
AbiomedOct 10, 2023 - Use cautionMedical device
Abiomed, Inc. recalls Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Abiomed recalls Impella RP Flex with SmartAssist pumps due to higher risk of blood clots forming and breaking loose, potentially causing reduced blood flow or hemolysis.
AbiomedJun 29, 2023 - Stop using nowMedical device
Abiomed, Inc. recalls Impella LD intravascular micro axial blood pump, Product Number 005082
Abiomed recalls Impella LD blood pumps (Product 005082) due to potential impeller blade damage from stent interaction, risking low blood flow and embolization.
AbiomedJun 14, 2023 - Use cautionMedical device
Abiomed, Inc. recalls Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Abiomed recalls 14Fr Low Profile Introducer Set (Product #1000457) due to potential sidearm detachment during pump explant from silicone oil contamination.
AbiomedMay 26, 2023 - Lower riskMedical device
Abiomed, Inc. recalls Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory
Abiomed recalls Impella 5.5 with SmartAssist catheters due to reported purge leaks. Affected units have specific serial numbers and product codes.
AbiomedApr 17, 2023 - Use cautionMedical device
Abiomed, Inc. recalls OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump
Abiomed recalls OXY-1 System Model 001-0500-001 used in cardiopulmonary bypass due to power interruptions causing therapy disruption and potential prolonged hypoxia. Affected units have specific serial numbers and software versions.
AbiomedDec 14, 2021 - Lower riskMedical device
Abiomed, Inc. recalls Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular
Abiomed recalls AIC controllers with software version 8.4 for potential pump recognition failure. Affected units require software update to prevent device malfunction.
AbiomedMar 1, 2021 - Use cautionMedical device
Abiomed, Inc. recalls lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock
Abiomed recalls lmpella CP with Smart Assist Model 0048-0003 due to incorrect programming that may cause pump migration and injury during cardiogenic shock support.
AbiomedSep 4, 2019
Abiomed, Inc. recall questions
How many recalls has Abiomed, Inc. had?
81 recalls from Abiomed, Inc. are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Abiomed, Inc. recall?
Abiomed, Inc. recalls Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions, dated Aug 12, 2026. Every Abiomed, Inc. recall is listed on this page, newest first.
Why are Abiomed, Inc. products recalled?
The most common reasons on record: Potential for thrombus formation during prolonged use of the introducer. (4); Pump not detected as connected to controller due to software issue. (2).
What should I do if I have a recalled Abiomed, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Abiomed, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.