BEUDAMED
    FDA Recall Terminated

    ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.

    Recall: Z-1315-04 · Initiated July 12, 2004

    Recall

    Recall Number
    Z-1315-04
    Event Number
    29517
    Firm
    Datascope Interventional Products Division
    FEI Number
    3003071194
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 12, 2004
    Posted
    August 7, 2004
    Terminated
    November 22, 2004
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430

    Description

    ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.

    Reason

    The motor may fail to activate when the on/off switch is pressed.

    Action

    Letter dated July 16, 2004 was mailed via US mail, return receipt requested.

    Distribution

    The product was shipped nationwide to 243 direct accounts. and to 7 government accounts.

    Quantity

    892