BEUDAMED
    FDA Recall Open, Classified

    Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

    Recall: Z-2319-2024 · Initiated May 31, 2024

    Recall

    Recall Number
    Z-2319-2024
    Event Number
    94833
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    OZD
    Status
    Open, Classified
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    May 31, 2024
    Posted
    July 17, 2024
    Address
    24 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

    Reason

    Nine (9) Impella CP pumps failed inspection and were inadvertently released.

    Action

    On May 31, 2024 consignees were contacted by phone with a script followed-up by sending URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters to consignees. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1.Examine your inventory immediately to determine if you have product subject to this recall(removal). QUARANTINE AND DO NOT USE THE SUBJECT PRODUCTS. 2.Your Abiomed Representatives have been provided instructions to support facilitation of locating, separating, and returning affected product for replacement. Work with your Abiomed Representative toreview, complete all fields, and sign the Business Response Form attached on page 4. IMPORTANT:The Business Response Form must be completed even if you have used any units of the subjectproduct on hand. 3.Forward this notice to any personnel in your facility who need to be informed. 4.If any of the product subject to this recall (removal) has been forwarded to another facility, contact thatfacility and provide a copy of this notice to the relevant personnel. 5.Post a copy of this notice in a visible area for awareness of this field safety notice. 6.As with any medical device, adverse reactions or quality problems experienced with the use of this productshould be reported to the FDA s MedWatch Adverse Event Reporting Program using the link below: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting- program/reporting-serious-problems-fda Please contact Abiomed Customer Service, 1-800-422-8666, option 2 (email [email protected] or contact your local clinical field staff if you have questions or concerns regarding this notice.

    Distribution

    Domestic only: FL, MA, OH TX.

    Quantity

    9 units