BEUDAMED
    FDA Recall Terminated

    Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000

    Recall: Z-0292-04 · Initiated November 19, 2003

    Recall

    Recall Number
    Z-0292-04
    Event Number
    27884
    Firm
    Guidant Cardiac Surgery
    FEI Number
    3000719698
    Product Code
    HET
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 19, 2003
    Posted
    July 20, 2004
    Terminated
    March 9, 2004
    Address
    3200 Lakeside Dr, Santa Clara, CA, 95054-2807

    Description

    Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000

    Reason

    VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.

    Action

    On 11/19/03, the firm issued letters via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

    Distribution

    There are a total of 130 consignees that received the recalled product distributed by Guidant. The firm has identified 0 (zero) wholesaler dealers, 7 distributors or affiliate companies, 0 (zero) retailers and 123 hospitals that received the recalled product distributed by Guidant. The recalled product was distributed in the United States and internationally. Recalled product was distributed by the firm to one (1) government account: USAF Medical Center Keesler, 1301 I Street, Keesler Air Force Base, MS 39534, (228) 377-2778. International countries include: Puerto Rico, Belgium, Chile, France, Germany, Italy and Kuwait.

    Quantity

    2597 units