Fresh Recalls

Abiomed recalls

25 recent recalls on record for Abiomed in connected official government data as of October 22, 2026 at 12:00 PM UTC.

Models with recalls

ABIOMED Impella 5 (2)ABIOMED Impella CP Introducer Kit 14 Fr (3)ABIOMED Impella CP Set (3)ABIOMED Impella CP Smart Assist Set (1)ABIOMED Impella RP Flex with SmartAssist Set (1)ABIOMED Insertion Kit (1)ABIOMED Intro Kit (1)ABIOMED Introducer Kit 23 Fr (1)Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP (1)Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP (1)Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro (2)Automated Impella Controller (AIC) (2)Automated Impella Controller (AIC) with the below product descriptions and corresponding P (3)Impella CP Set with SmartAssist (1)Impella Optical Controller (1)Impella Optical Controller with the below product descriptions and corresponding Product C (1)

All Abiomed recalls

FDA Class II · Medical device · September 30, 2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc.

Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of t…

Official ID Z-3251-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Impella Optical Controller recall — Abiomed, Inc.

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Official ID Z-3150-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Impella Optical Controller with the below product descriptions and corresponding Product C recall — Abiomed, Inc.

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Official ID Z-3149-2026 · Official record ↗

FDA Class I · Medical device · September 23, 2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc.

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Official ID Z-3148-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Intro Kit recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2693-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Insertion Kit recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2692-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2691-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Smart Assist Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2690-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2689-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella 5 recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2688-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella 5 recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2687-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2686-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2685-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Introducer Kit 23 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2684-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Introducer Kit 14 Fr recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2683-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella CP Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2682-2026 · Official record ↗

FDA Class I · Medical device · July 22, 2026

ABIOMED Impella RP Flex with SmartAssist Set recall — Abiomed, Inc.

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua…

Official ID Z-2681-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Official ID Z-2602-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Official ID Z-2601-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Official ID Z-2600-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Official ID Z-2599-2026 · Official record ↗

FDA Class I · Medical device · June 24, 2026

Impella CP Set with SmartAssist recall — Abiomed, Inc.

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Official ID Z-2457-2026 · Official record ↗

FDA Class I · Medical device · June 24, 2026

Automated Impella Controller (AIC) recall — Abiomed, Inc.

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Official ID Z-2360-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc.

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in cert…

Official ID Z-2238-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Automated Impella Controller (AIC) recall — Abiomed, Inc.

A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented th…

Official ID Z-2211-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.