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
Jun 11, 2026 ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 2... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containi... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP;... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; co... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Produc... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containi... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; ... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, cont... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Produc... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Intro... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550,... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, cont... A potential for introducer sheath leakage from under the sheath cap and along... Class I
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella In... A potential for introducer sheath leakage from under the sheath cap and along... Class I
May 22, 2026 Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... Potential for thrombus formation during prolonged use of the introducer. Class I
May 22, 2026 Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set ... Potential for thrombus formation during prolonged use of the introducer. Class I
May 22, 2026 Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set ... Potential for thrombus formation during prolonged use of the introducer. Class I
May 22, 2026 Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... Potential for thrombus formation during prolonged use of the introducer. Class I
May 18, 2026 Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, ... Exposure to the low purge pressure occurrence may result in persistent low pu... Class I
May 14, 2026 Automated Impella Controller (AIC), for use with left heart support blood pum... Potential software error in the Automated Impella Controller ("AIC" ) when us... Class I
Apr 20, 2026 Automated Impella Controller (AIC); Product Code: 0042-0000-US; A retrospective review identified that there are AIC units requiring specific... Class I
Feb 18, 2026 Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labe... Increased risk of purge leaks with Generation 1 purge cassettes. Class I
Feb 16, 2026 Automated Impella Controller (AIC), labeled as the following with correspondi... Potential that the "Purge System Blocked" alarm display on the Automated Imp... Class I
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

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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