BEUDAMED
    FDA Recall Terminated

    Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.

    Recall: Z-0118-2007 · Initiated June 27, 2006

    Recall

    Recall Number
    Z-0118-2007
    Event Number
    35827
    Firm
    Enpath Medical, Inc.
    FEI Number
    2183787
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2006
    Posted
    November 2, 2006
    Terminated
    April 14, 2007
    Address
    15301 Highway 55, Plymouth, MN, 55447-1418

    Description

    Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.

    Reason

    Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.

    Action

    Enpath''s three Distributors were notified via letter or telephone on June 27th, 29th and July 6th with a description of the problem and further distribution or use of any remaining product should cease immediately. Instructed to notify their customers about the product and forward to Enpath for evaluation.

    Distribution

    CA, MA

    Quantity

    2494 Units