FreshRecalls

Abiomed recalls

8 recent recalls on record for Abiomed in CPSC, NHTSA, and FDA data as of July 24, 2026 at 1:09 AM UTC.

Models with recalls

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 (1)Impella CP Set with SmartAssist (1)

All Abiomed recalls

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 July 24, 2026 at 1:09 AM UTC.