BEUDAMED
    FDA Recall Terminated

    DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . DISCOVERY II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering both adaptive-rate therapy and conventional pacing therapy. These pacemakers provide various levels of therapeutic and diagnostic functionality. DISCOVERY II adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity.

    Recall: Z-1036-05 · Initiated July 18, 2005

    Recall

    Recall Number
    Z-1036-05
    Event Number
    32681
    Firm
    Guidant Corporation
    FEI Number
    2124215
    Product Code
    LWP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 18, 2005
    Posted
    July 28, 2005
    Terminated
    January 5, 2007
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . DISCOVERY II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering both adaptive-rate therapy and conventional pacing therapy. These pacemakers provide various levels of therapeutic and diagnostic functionality. DISCOVERY II adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity.

    Reason

    A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

    Action

    INITIAL RECALL Urgent medical Device Safety Information & Corrective Action letter dated 07/18/05 was issued to physicians listing clinical Implications and patient management recommendations. EXPANDED RECALL Press was issued January 23, 2006. Urgent Medical Device Safety Information & Corrective Action letter, dated 01/21/06, was issued to physicians listing a summary of previous communication to physicians, advisory population update, and information relative to a second population of devices manufactured between October 19, 1998 and December 5, 2000. This letter gives the observed rate of occurrence, clinical implications, projected rate of occurrence and recommendations.

    Distribution

    worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cyprus, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guyana, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Singapore,Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan ROC, Turkey, United Kingdom, Uruguay and Venezuela. EXPANDED RECALL additional countries include: China, Croatia, Korea. Lithuania, Madagascar, Maldives, Malta, Monaco, Nepal and Thailand.

    Quantity

    INITIAL RECALL 414. EXPANDED RECALL 2,367