Abiomed, Inc. recalls
34 recalls filed under Abiomed, Inc.. The most recent was published September 30, 2026.
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Class II · 25 days ago
Abiomed, Inc. Automated Impella Controller with the below product descriptions recall: Retrospective report of issues remedied in 2019 with firmware and software
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected…
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Class I · last month
Abiomed, Inc. Impella Optical Controller, Automated Impella Controller recall: The potential for purge cassette recognition issues due to the failure
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
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Class I · last month
Abiomed, Inc. Impella Optical Controller with the below product descriptions recall: The potential for purge cassette recognition issues due to the failure
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
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Class I · last month
Abiomed, Inc. Automated Impella Controller with the below product descriptions recall: The potential for purge cassette recognition issues due to the failure
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
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Class I · 3 months ago
Abiomed Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441 recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Intro Kit, 14Fr x 13 and 25 cm, Pkgd, JP recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella 5.5 Smart Assist Set, JP recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella CP Set, Pump Set Code 0048-0044 recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella RP Flex with SmartAssist Set recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella 5.5 SmartAssist S2 Set, JP recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella CP Introducer Kit 14 Fr, 25 cm recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella CP Set, Pump Set Code 0048-0014 recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella CP Introducer Kit 14 Fr, 13 and 25 cm recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella CP Introducer Kit 14 Fr, 13 cm recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Abiomed Impella CP Set, Pump Set Code 0048-0003 recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 4 months ago
Abiomed Impella CP Set with SmartAssist containing affected 14Fr Low recall: Potential for thrombus formation during prolonged use of the introducer
Potential for thrombus formation during prolonged use of the introducer.
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Class I · 4 months ago
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall: Potential for thrombus formation during prolonged use of the introducer
Potential for thrombus formation during prolonged use of the introducer.
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Class I · 4 months ago
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall: Potential for thrombus formation during prolonged use of the introducer
Potential for thrombus formation during prolonged use of the introducer.
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Class I · 4 months ago
Abiomed Impella CP Set with SmartAssist containing affected 14Fr Low recall: Potential for thrombus formation during prolonged use of the introducer
Potential for thrombus formation during prolonged use of the introducer.
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Class I · 4 months ago
Abiomed, Inc. Automated Impella Controller , for use with left heart support blood recall: Potential software error in the Automated Impella Controller ("AIC" )
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
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Class I · 4 months ago
Abiomed, Inc. Impella CP Set with SmartAssist. Product Codes: 1000080 recall: Exposure to the low purge pressure occurrence may result in persistent low
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of…
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Class I · 5 months ago
Abiomed, Inc. Automated Impella Controller recall: A retrospective review identified that there are AIC units requiring specific
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware…
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.