BEUDAMED
    FDA Recall Terminated

    Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)

    Recall: Z-1631-2010 · Initiated September 10, 2009

    Recall

    Recall Number
    Z-1631-2010
    Event Number
    53322
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 10, 2009
    Posted
    May 20, 2010
    Terminated
    April 5, 2012
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)

    Reason

    Boston Scientific has determined that alert conditions for a limited subset of out-of-range Daily Measurements related to leads may not be recognized by Model 6476 (United States) or Model 6468 (Europe) LATITUDE in-home communicators. If a communicator fails to recognize a valid alert situation, notification for this or subsequent alerts for the same test will not be displayed for physician review

    Action

    Consignees were sent on 9/10/09 a Boston Scientific "Urgent Medical Device Information" letter dated September 9, 2009. The letter was addressed to "Dear Doctor". The letter provided the information related to the LATITUDE Patient Management system recall as to Background, Description, Rate of Occurrence, Patient management, Devices Affected and Further Information. Patients were also sent a Boston Scientific letter dated September 9, 2009. The letter addressed Background information, Why are we communicating, What You Should Do and Questions.

    Distribution

    All States in the US including Puerto Rico United Kingdom, Switzerland, Netherlands, Italy, Germany, France, Finland, Denmark, Belgium, Austria

    Quantity

    25,656 (USA), 390 (OUS)