The Recall Desk

Manufacturer

Abiomed, Inc.

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

What the numbers show

Total
79
Critical
4
Severe
40
Most recent
2026-07-22

Of the 79 recalls from Abiomed, Inc. we have scored against our rubric, 4 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 40 (51%) are Severe.

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 79

  • 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-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-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-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-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-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-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-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-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-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-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-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-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-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
  • 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-2360-2026·2026-06-24

    Automated Impella Controller software error affects left ventricular support devices

    Automated Impella Controllers are being recalled because of a potential software error when used with left ventricular Impella devices. 10,297 units are affected.

    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
  • SevereFDA (Devices)·Z-2457-2026·2026-06-24

    Impella CP sets may lose mechanical circulatory support from low purge pressure

    Impella CP Sets with SmartAssist are being recalled because a low purge pressure occurrence may cause persistent alarms and, in some cases, interruption or loss of circulatory support.

    Product
    Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2211-2026·2026-06-03

    Automated Impella Controllers await four pending hardware safety updates

    Automated Impella Controllers that have not been through Abiomed's servicing process are pending four hardware updates addressing motor control, startup and pump stop risks.

    Product
    Automated Impella Controller (AIC); Product Code: 0042-0000-US;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2238-2026·2026-06-03

    Automated Impella Controllers recalled over alarm, power and purge cassette faults

    Automated Impella Controllers sold outside the US are being recalled over alarm failures, power-path faults, electrical-short risks, inaccurate motor-current sensing and purge cassette misalignment.

    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
  • SevereFDA (Devices)·Z-1591-2026·2026-04-08

    Impella controller purge blocked alarm may be delayed on older pumps

    Abiomed is recalling Automated Impella Controllers because the Purge System Blocked alarm display could be delayed when using first generation Impella 5.5 pumps.

    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
  • SevereFDA (Devices)·Z-1589-2026·2026-04-08

    Impella purge cassettes recalled as Class I over purge leak risk

    Purge Cassettes sold within Impella Pump Sets and individually packaged are being recalled because of an increased risk of purge leaks with Generation 1 purge cassettes.

    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
  • SevereFDA (Devices)·Z-1469-2026·2026-03-11

    Abiomed Impella RP with SmartAssist recalled as Class I

    Abiomed is recalling the Impella RP with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.

    Product
    Impella RP with SmartAssist. Product Code: 0046-0035.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1470-2026·2026-03-11

    Abiomed Impella RP Flex recalled as Class I over sensor drift

    Abiomed is recalling the Impella RP Flex with SmartAssist because the differential pressure sensor may malfunction, causing sensor values to drift. The FDA has classified this recall as Class I.

    Product
    Impella RP Flex with SmartAssist. Product Code: 1000323.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

AbioMed

medical devices company based in Danvers, Massachusetts, USA

Country
United States
Founded
1981
Parent company
Johnson & Johnson

Official website

Source: Wikidata (Q4667884), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.