The Recall Desk

Manufacturer

Abiomed, Inc.

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

What the numbers show

Total
83
Critical
4
Severe
43
Most recent
2026-09-30

Of the 83 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 43 (52%) 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.

76–83 of 83

  • SevereFDA (Devices)·Z-2112-2023·2023-07-26

    Impella 5.0 Blood Pump Recalled for Potential Impeller Blade Destruction Risk

    Abiomed's Impella 5.0 intravascular blood pump is recalled due to risk of impeller blade destruction when interacting with heart valve replacements. The damaged pump can cause reduced blood flow and potentially release fractured material into the bloodstream.

    Product
    Impella 5.0 intravascular micro axial blood pump, Product Number 005062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2114-2023·2023-07-26

    Abiomed Impella 5.5 pump recalled due to impeller blade damage risk

    Abiomed is recalling the Impella 5.5 with SmartAssist pump due to a risk of impeller blade destruction when used with aortic valve replacement devices. Damage can result in low blood flow and systemic embolization, where broken pump pieces may enter the bloodstream.

    Product
    Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2111-2023·2023-07-26

    Impella 2.5 blood pump recalled due to impeller blade damage risk

    Impella 2.5 intravascular blood pumps may experience unintended interaction with aortic valve replacement stents, damaging impeller blades and reducing blood flow. Fragments may circulate through the bloodstream.

    Product
    Impella 2.5 intravascular micro axial blood pump, Product Number 005042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2115-2023·2023-07-26

    Impella CP Blood Pump Recalled for Blade Destruction From Stent Interaction

    Abiomed's Impella CP cardiac pump can be damaged by interaction with replacement heart valves, potentially causing blood clots. The FDA classified this as a Class I recall of 9,252 units worldwide.

    Product
    Impella CP intravascular micro axial blood pump, Product Number 0048-0032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2023·2023-07-19

    Abiomed Introducer Set Recall Due to Sidearm Detachment Risk

    Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.

    Product
    Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1590-2023·2023-05-24

    Impella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate

    Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.

    Product
    Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0550-2022·2022-02-09

    OXY-1 System Console Experiences Power Interruption During Use

    OXY-1 System consoles used during cardiac support procedures may experience power interruptions that disrupt patient therapy, potentially causing prolonged oxygen deprivation.

    Product
    OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0345-2020·2019-11-13

    Abiomed lmpella CP Pump Recalled for Incorrect Programming and Disabled Alarms

    Abiomed is recalling one lmpella CP pump with Smart Assist due to incorrect programming that disabled safety alarms and altered pump operation.

    Product
    lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
    Category
    Medical Device
    Distribution
    1 state

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.