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Abiomed, Inc. FDA Recalls
80 recalls on file across devices, 45 of them Class I and 76 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical ContrClass IAug 12, 2026The potential for purge cassette recognition issues due to t |
| Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella ContrClass IAug 12, 2026The potential for purge cassette recognition issues due to t |
| Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions anClass IAug 12, 2026The potential for purge cassette recognition issues due to t |
| ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. hClass IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cmClass IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long TapClass IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessoriClass IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pumClass IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-Class IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer PClass IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Class IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long TapClass IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-300Class IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product CodClass IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-30Class IJun 11, 2026A potential for introducer sheath leakage from under the she |
| ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessoriClass IJun 11, 2026A potential for introducer sheath leakage from under the she |
| Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product CClass IMay 22, 2026Potential for thrombus formation during prolonged use of the |
| Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product CClass IMay 22, 2026Potential for thrombus formation during prolonged use of the |
| Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Class IMay 22, 2026Potential for thrombus formation during prolonged use of the |
| Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25Class IMay 22, 2026Potential for thrombus formation during prolonged use of the |
| Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.Class IMay 18, 2026Exposure to the low purge pressure occurrence may result in |
| Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponClass IMay 14, 2026Potential software error in the Automated Impella Controller |
| Automated Impella Controller (AIC); Product Code: 0042-0000-US;Class IApr 20, 2026A retrospective review identified that there are AIC units r |
| Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configuratClass IFeb 18, 2026Increased risk of purge leaks with Generation 1 purge casset |
| Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella ControllerClass IFeb 16, 2026Potential that the "Purge System Blocked" alarm display on |
| Impella RP with SmartAssist. Product Code: 0046-0035.Class IJan 27, 2026Differential pressure (dP) sensor in Impella RP devices may |
| Impella RP. Product Code: 0046-0011.Class IJan 27, 2026Differential pressure (dP) sensor in Impella RP devices may |
| Impella RP Flex with SmartAssist. Product Code: 1000323.Class IJan 27, 2026Differential pressure (dP) sensor in Impella RP devices may |
| Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.Class IIDec 4, 2025Device packaged in incorrect outer box carton. |
| Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Class IOct 1, 2025Potential cybersecurity vulnerabilities related to the opera |
| Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect Class ISep 16, 2025Potential for Automated Impella Controller (AIC) purge press |
| Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella CoClass IAug 20, 2025Specific Automated Impella Controllers (AICs) that have a Pu |
| Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella ContrClass IJun 23, 2025A potential issue with the Automated Impella Controller (AIC |
| Impella RP Flex with SmartAssist; Product Number: 1000323;Class IDec 12, 2024Optical Sensors have been damaged due to physical interactio |
| Impella RP with SmartAssist; Product Number: 0046-0035;Class IDec 12, 2024Optical Sensors have been damaged due to physical interactio |
| Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella CP Smart Assist Set APAC; Product Code: 0048-0047;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Pump 371 14F LT CMR Set; Product Code: 0048-0045;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Pump 381 Pump Set (US); Product Code: 1000080;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella 5.5 Set AU; Product Code: 1000361;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella CP Smart Assist Set; Product Code: 1000402;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella CP Smart Assist Set, EU; Product Code: 0048-0014;Class IIAug 5, 2024A potential device interaction between the Shockwave Coronar |
| Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pumpClass IMay 31, 2024Nine (9) Impella CP pumps failed inspection and were inadver |
| Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product CodeClass IIDec 27, 2023New warnings are being added to the Instructions for Use for |
| Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product CodClass IDec 27, 2023IFU has been updated to include warnings about the risk of t |
| Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remoteClass IIDec 6, 2023The following features have been disabled from the web-based |
| Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of theClass IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inteClass IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella CaClass IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the ImpClass IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of thClass IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the ImpClass IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Class IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of theClass IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for iClass IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the bodyClass IINov 7, 2023Hole(s) to the outer pouch of the Introducer Kits (both tray |
| Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.Class IIOct 10, 2023Pump not detected as connected to controller due to software |
| Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.Class IIOct 10, 2023Pump not detected as connected to controller due to software |
| Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323Class IJun 29, 2023A higher than expected rate of thrombus formation or deposi |
| Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100Class IJun 14, 2023There is a potential risk for unintentional interaction of t |
| Impella 5.0 intravascular micro axial blood pump, Product Number 005062Class IJun 14, 2023There is a potential risk for unintentional interaction of t |
| Impella CP intravascular micro axial blood pump, Product Number 0048-0032Class IJun 14, 2023There is a potential risk for unintentional interaction of t |
| Impella 2.5 intravascular micro axial blood pump, Product Number 005042Class IJun 14, 2023There is a potential risk for unintentional interaction of t |
| Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080Class IJun 14, 2023There is a potential risk for unintentional interaction of t |
| Impella LD intravascular micro axial blood pump, Product Number 005082Class IJun 14, 2023There is a potential risk for unintentional interaction of t |
| Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457Class IIMay 26, 2023There was one complaint that the sidearm of the device detac |
| Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory sClass IApr 17, 2023The Impella 5.5 pump experienced a heightened complaint rate |
| OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, PumClass IDec 14, 2021The firm has received complaints of the OXY-1 System Console |
| Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella VentricularClass IIMar 1, 2021Retrospective reporting for the release of Technical Bulleti |