The Recall Desk

Manufacturer

Abiomed, Inc.

75 recalls in our database name Abiomed, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 75

  • SevereFDA (Devices)·Z-2685-2026·2026-07-22

    Abiomed Impella CP Introducer Kit heart pump accessory recall

    Abiomed is recalling Impella CP Introducer Kits worldwide due to potential leakage from the introducer sheath that cannot be visually detected by users. The manufacturing defect affects 1,540 units across multiple countries.

    Product
    ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2693-2026·2026-07-22

    ABIOMED Intro Kit Heart Pump Introducer Sheath Leakage Risk

    Abiomed, Inc. is recalling ABIOMED Intro Kit heart pump introducer sheaths due to potential leakage from under the sheath cap and along hub score lines. The manufacturing defects are not visually detectable by users.

    Product
    ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2681-2026·2026-07-22

    ABIOMED Impella RP Flex heart pump introducer sheath leakage risk

    Abiomed is recalling the Impella RP Flex heart pump due to potential introducer sheath leakage from the sheath cap and hub score lines. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2687-2026·2026-07-22

    ABIOMED Impella 5.5 Heart Pump Introducer Sheath Leakage Risk Recall

    Abiomed is recalling the Impella 5.5 Smart Assist Set heart pump due to potential leakage from introducer sheaths. The defect is not visually detectable and affects all affected pump sets worldwide.

    Product
    ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2690-2026·2026-07-22

    Abiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage

    Abiomed is recalling the Impella CP Smart Assist Set due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. These manufacturing issues are not visually detectable.

    Product
    ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2689-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2692-2026·2026-07-22

    ABIOMED Insertion Kit heart pump accessories introducer sheath leakage

    Abiomed is recalling ABIOMED Insertion Kits due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.

    Product
    ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2686-2026·2026-07-22

    ABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath

    Abiomed, Inc. is recalling ABIOMED Impella CP Introducer Kit 14 Fr units worldwide due to potential introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable.

    Product
    ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2683-2026·2026-07-22

    ABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall

    ABIOMED Impella CP Introducer Kit 14Fr is being recalled due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.

    Product
    ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2684-2026·2026-07-22

    ABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk

    Abiomed is recalling ABIOMED Introducer Kit 23 Fr due to potential sheath leakage from manufacturing defects. The leakage risk is not visually detectable and affects all current batches worldwide.

    Product
    ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2691-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk

    ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2682-2026·2026-07-22

    ABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk

    Abiomed is recalling the Impella CP heart pump set (87,277 units worldwide) due to potential leakage from the introducer sheath that cannot be visually detected by users. The defect affects the 14Fr and 23Fr introducers included in every pump set.

    Product
    ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2688-2026·2026-07-22

    Abiomed Impella 5.5 SmartAssist S2 heart pump introducer sheath leakage risk

    Abiomed is recalling Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines that may not be visible to users.

    Product
    ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2601-2026·2026-07-01

    Abiomed Impella CP Set with SmartAssist 10th Generation Introducer Kits Recalled

    Abiomed is recalling certain Impella CP Set with SmartAssist (10th Generation) units with affected 14Fr Low Profile Introducer Kits due to potential for thrombus (blood clot) formation during prolonged use.

    Product
    Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2602-2026·2026-07-01

    Abiomed Impella CP Set with SmartAssist 10th Generation Introducer Kit Recall

    Abiomed is recalling Impella CP Set with SmartAssist (10th Generation) containing 14Fr Low Profile Introducer Kits due to potential thrombus (blood clot) formation during prolonged use of the introducer.

    Product
    Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2600-2026·2026-07-01

    Abiomed Impella CP Introducer Kit Recalled for Thrombus Risk

    Abiomed is recalling the 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP due to potential thrombus formation during prolonged use. The recall affects 17 units distributed in the United States and Japan.

    Product
    Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2599-2026·2026-07-01

    Abiomed Impella CP Introducer Kit recalled for thrombus formation risk

    Abiomed is recalling 3 units of the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP due to potential for blood clot formation during prolonged use.

    Product
    Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2360-2026·2026-06-24

    Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the foll

    Pending LLM rewrite. Source: FDA_DEVICE Z-2360-2026.

    Product
    Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2238-2026·2026-06-03

    Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod

    Pending LLM rewrite. Source: FDA_DEVICE Z-2238-2026.

    Product
    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, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1591-2026·2026-04-08

    Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1

    Pending LLM rewrite. Source: FDA_DEVICE Z-1591-2026.

    Product
    Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Produc
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-1589-2026·2026-04-08

    Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in

    Pending LLM rewrite. Source: FDA_DEVICE Z-1589-2026.

    Product
    Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge C
    Category
    Medical Device
    Distribution
    0 states
  • Severity pendingFDA (Devices)·Z-1470-2026·2026-03-11

    Impella RP Flex with SmartAssist. Product Code: 1000323.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1470-2026.

    Product
    Impella RP Flex with SmartAssist. Product Code: 1000323.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1471-2026·2026-03-11

    Impella RP. Product Code: 0046-0011.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1471-2026.

    Product
    Impella RP. Product Code: 0046-0011.
    Category
    Medical Device
    Distribution
    Distributed nationwide