Abiomed, Inc.

Complete recall history across all FDA and CPSC categories — 56 total recalls

Abiomed, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (56)

FDA medical device enforcement actions by Abiomed, Inc.. Showing most recent 50.

Date Product Reason Class
Jan 27, 2026 Impella RP. Product Code: 0046-0011. Differential pressure (dP) sensor in Impella RP devices may malfunction, caus... Class I
Jan 27, 2026 Impella RP with SmartAssist. Product Code: 0046-0035. Differential pressure (dP) sensor in Impella RP devices may malfunction, caus... Class I
Jan 27, 2026 Impella RP Flex with SmartAssist. Product Code: 1000323. Differential pressure (dP) sensor in Impella RP devices may malfunction, caus... Class I
Dec 4, 2025 Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. Device packaged in incorrect outer box carton. Class II
Oct 1, 2025 Automated Impella Controller (AIC), used for left heart support blood pump, l... Potential cybersecurity vulnerabilities related to the operating system in th... Class I
Sep 16, 2025 Automated Impella Controller (AIC) labeled as the following with correspondin... Potential for Automated Impella Controller (AIC) purge pressure issues due to... Class I
Aug 20, 2025 Automated Impella Controller (AIC) with the below brands and product codes. U... Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit... Class I
Jun 23, 2025 Automated Impella Controller (AIC), used in left heart support blood pump, in... A potential issue with the Automated Impella Controller (AIC) not detecting a... Class I
Dec 12, 2024 Impella RP with SmartAssist; Product Number: 0046-0035; Optical Sensors have been damaged due to physical interaction between the inl... Class I
Dec 12, 2024 Impella RP Flex with SmartAssist; Product Number: 1000323; Optical Sensors have been damaged due to physical interaction between the inl... Class I
Aug 5, 2024 Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella 5.5 Set AU; Product Code: 1000361; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Pump 371 14F LT CMR Set; Product Code: 0048-0045; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella CP Smart Assist Set, EU; Product Code: 0048-0014; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Pump 381 Pump Set (US); Product Code: 1000080; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella CP Smart Assist Set; Product Code: 1000402; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella CP Smart Assist Set APAC; Product Code: 0048-0047; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
Aug 5, 2024 ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; A potential device interaction between the Shockwave Coronary IVL Catheter an... Class II
May 31, 2024 Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left hear... Nine (9) Impella CP pumps failed inspection and were inadvertently released. Class I
Dec 27, 2023 Impella catheters - Intravascular micro axial blood pumps that support a pati... IFU has been updated to include warnings about the risk of the inlet perforat... Class I
Dec 27, 2023 Impella catheters - Intravascular micro axial blood pumps that support a pati... New warnings are being added to the Instructions for Use for all affected pro... Class II
Dec 6, 2023 Impella Connect, software portal for online device management that allows cli... The following features have been disabled from the web-based portal because t... Class II
Nov 7, 2023 Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, ... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Nov 7, 2023 Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Nov 7, 2023 Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introd... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Nov 7, 2023 Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are ... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Nov 7, 2023 Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introdu... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Nov 7, 2023 Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Nov 7, 2023 Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introdu... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Nov 7, 2023 Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introdu... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Nov 7, 2023 Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Nov 7, 2023 Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040,... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed... Class II
Oct 10, 2023 Automated Impella Controller (AIC), product number 0042-000-US with software ... Pump not detected as connected to controller due to software issue. Class II
Oct 10, 2023 Automated Impella Controller (AIC), product number 0042-040-US with software ... Pump not detected as connected to controller due to software issue. Class II
Jun 29, 2023 Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product ... A higher than expected rate of thrombus formation or deposition has been obs... Class I
Jun 14, 2023 Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Nu... There is a potential risk for unintentional interaction of the Impella motor ... Class I
Jun 14, 2023 Impella CP intravascular micro axial blood pump, Product Number 0048-0032 There is a potential risk for unintentional interaction of the Impella motor ... Class I
Jun 14, 2023 Impella 2.5 intravascular micro axial blood pump, Product Number 005042 There is a potential risk for unintentional interaction of the Impella motor ... Class I
Jun 14, 2023 Impella CP with SmartAssist intravascular micro axial blood pump, Product Num... There is a potential risk for unintentional interaction of the Impella motor ... Class I
Jun 14, 2023 Impella 5.0 intravascular micro axial blood pump, Product Number 005062 There is a potential risk for unintentional interaction of the Impella motor ... Class I

View all 56 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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