Abiomed, Inc. recalls
34 recalls filed under Abiomed, Inc.. The most recent was published June 3, 2026.
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Class I · 5 months ago
Abiomed, Inc. Automated Impella Controller with the below product descriptions recall: Retrospective submission for following issues identified: 1. Alarm failures
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current…
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Class I · 7 months ago
Abiomed, Inc. Purge Cassette, sold within Impella Pump Sets and Individually recall: Increased risk of purge leaks with Generation 1 purge cassettes
Increased risk of purge leaks with Generation 1 purge cassettes.
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Class I · 7 months ago
Abiomed, Inc. Automated Impella Controller , labeled as the following recall: Potential that the "Purge System Blocked" alarm display on the Automated
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation…
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Class I · 8 months ago
Abiomed, Inc. Impella RP. Product Code: 0046-0011 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Class I · 8 months ago
Abiomed, Inc. Impella RP with SmartAssist. Product Code: 0046-0035 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Class I · 8 months ago
Abiomed, Inc. Impella RP Flex with SmartAssist. Product Code: 1000323 recall: Differential pressure (dP) sensor in Impella RP devices may malfunction
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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Class II · 9 months ago
Abiomed, Inc. Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set recall: Device packaged in incorrect outer box carton
Device packaged in incorrect outer box carton.
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Class I · 12 months ago
Abiomed, Inc. Automated Impella Controller labeled as the following recall: Potential for Automated Impella Controller (AIC) purge pressure issues
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
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Class I · 1+ years ago
Abiomed, Inc. Automated Impella Controller , used for left heart support blood pump recall: Potential cybersecurity vulnerabilities related to the operating system
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
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Class I · 1+ years ago
Abiomed, Inc. Automated Impella Controller with the below brands and product codes recall: Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased…
About this page
Abiomed, Inc. appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.