BEUDAMED
    FDA Recall Open, Classified

    Acrobat-i Positioner. Model Number C-XP-5000Z

    Recall: Z-0484-2025 · Initiated October 16, 2024

    Recall

    Recall Number
    Z-0484-2025
    Event Number
    95614
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    MWS
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    October 16, 2024
    Posted
    November 18, 2024
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Acrobat-i Positioner. Model Number C-XP-5000Z

    Reason

    Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

    Action

    MAQUET Cardiovascular LLC / Getinge notified consignees via letter FedEx 2-Day Delivery on 10/16/2024. Customers were instructed to forward the notification to all users and notify customers if further distributed, examine inventory and return any affected inventory, and to complete and return the MEDICAL DEVICE REMOVAL - RESPONSE FORM.

    Distribution

    Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.

    Quantity

    14,338 units