BEUDAMED
    FDA Recall Terminated

    Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075

    Recall: Z-0639-05 · Initiated February 14, 2005

    Recall

    Recall Number
    Z-0639-05
    Event Number
    31230
    Firm
    Boston Scientific
    FEI Number
    3001236349
    Product Code
    MTD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 14, 2005
    Posted
    March 18, 2005
    Terminated
    August 22, 2005
    Address
    2710 Orchard Pkwy, San Jose, CA, 95134-2012

    Description

    Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075

    Reason

    The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.

    Action

    All consignees were notified via customer letters sent out on 02/14/2005. Distributors outside the US will be formally notified via the firm's recall procedures.

    Distribution

    This product was distributed to 521 accounts worldwide.

    Quantity

    6694 units were distributed.