Abiomed, Inc.: 61 recalls on record

Recalls filed with 1 agency: FDA (61).

First recall on record: January 10, 2024. Most recent: September 23, 2026.

Risk classification: Class I: 30 · Class II: 31

Most recent recalls

DateAgencyProduct
September 23, 2026FDAAutomated Impella Controller (AIC) with the below product descriptions and corresponding …Z-3148-2026
September 23, 2026FDAImpella Optical Controller with the below product descriptions and corresponding Product …Z-3149-2026
September 23, 2026FDAImpella Optical Controller, Automated Impella Controller, Impella Connect Package with th…Z-3150-2026
July 22, 2026FDAABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr…Z-2681-2026
July 22, 2026FDAABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Produc…Z-2692-2026
July 22, 2026FDAABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing I…Z-2688-2026
July 22, 2026FDAABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-…Z-2691-2026
July 22, 2026FDAABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-…Z-2689-2026
July 22, 2026FDAABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing …Z-2683-2026
July 22, 2026FDAABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14…Z-2682-2026
July 22, 2026FDAABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Int…Z-2687-2026
July 22, 2026FDAABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, …Z-2685-2026
July 22, 2026FDAABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, …Z-2686-2026
July 22, 2026FDAABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introduce…Z-2690-2026
July 22, 2026FDAABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introduc…Z-2684-2026
July 22, 2026FDAABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing …Z-2693-2026
July 1, 2026FDAAbiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code…Z-2600-2026
July 1, 2026FDAAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pr…Z-2601-2026
July 1, 2026FDAAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pr…Z-2602-2026
July 1, 2026FDAAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code…Z-2599-2026
June 24, 2026FDAImpella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.Z-2457-2026
June 24, 2026FDAAutomated Impella Controller (AIC), for use with left heart support blood pump. Labeled …Z-2360-2026
June 3, 2026FDAAutomated Impella Controller (AIC) with the below product descriptions and corresponding …Z-2238-2026
June 3, 2026FDAAutomated Impella Controller (AIC); Product Code: 0042-0000-US;Z-2211-2026
March 11, 2026FDAImpella RP Flex with SmartAssist. Product Code: 1000323.Z-1470-2026

Questions about this company

How many recalls does Abiomed, Inc. have?
Recalert has 61 U.S. recalls on record for Abiomed, Inc., published between January 10, 2024 and September 23, 2026.
What was the most recent Abiomed, Inc. recall?
FDA recall Z-3148-2026, published September 23, 2026: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Package…
Which agencies have handled Abiomed, Inc. recalls?
Abiomed, Inc. appears as the recalling firm in recalls from: FDA (61).

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