BEUDAMED
    FDA Recall Terminated

    Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).

    Recall: Z-0311-04 · Initiated October 2, 2003

    Recall

    Recall Number
    Z-0311-04
    Event Number
    27410
    Firm
    Heartport Inc Route
    FEI Number
    3000719637
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 2, 2003
    Posted
    January 9, 2004
    Terminated
    October 19, 2005
    Address
    22 West, Somerville, NJ, 08876

    Description

    Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).

    Reason

    Damaged hemostasis valves that prevent or present difficulty when inserting catheters.

    Action

    Recall was first initiated on/about 10/2/03 by phone domestically from the Director of Marketing to the firm''s Sales Force (no phone script available). Following the initial phone call, formal recall letters were sent out on 10/6/03 to: Director of CV Suite; Director of the OR; and Director of Material Management of each hospital.

    Distribution

    Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.

    Quantity

    13 units