Temporary Non-Roller Type Left Heart Support Blood Pump
FDA product code OZD · Class III (high risk) · Cardiovascular
A blood pump that provides temporary full or partial left heart support
0510(k) clearances
1PMA approvals
47recalls
PMA approvals
- P140003 IMPELLA 2.5 System · Abiomed, Inc. · 03/23/2015
Recalls
| Recall | Product | Firm | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 08/12/2026Open, 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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. | Abiomed, Inc. | 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… | Abiomed, Inc. | 02/16/2026Open, 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. | Abiomed, Inc. | 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… | Abiomed, Inc. | 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. | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 06/23/2025Open, 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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. | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 12/27/2023Open, 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. | Abiomed, Inc. | 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. | Abiomed, Inc. | 10/10/2023Terminated |
| 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 06/14/2023Open, 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. | Abiomed, Inc. | 04/17/2023Open, Classified |
| 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 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… | Abiomed, Inc. | 01/17/2011Open, Classified |