Events

Recall of LATITUDE Patient Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific CRM Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60244
  • Event Risk Class
    Class 2
  • Event Number
    Z-0333-2012
  • Event Initiated Date
    2011-10-12
  • Event Date Posted
    2011-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104862
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implantable cardioverter defibrillator (non-crt) - Product Code LWS
  • Reason
    Current boston scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and latitude monitoring system via the daily measurements feature. a measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a red alert within latitude (if activated). however, the mea.
  • Action
    Boston Scientific sent an "IMPORTANT DIAGNOSTIC INFORMATION" letter dated October 2011 to all affected customers. The letter described the product, problem and actions to be taken by the customers.

Device

LATITUDE Patient Management System
  • Model / Serial
    Models 6441*, 6442*, 6465*, 6488 (USA).
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, CANADA, AUSTRALIA, NEW ZEALAND, CYPRUS, CZECH REPUBLIC, GREECE, GUADELOUPE, HUNGARY, BANGLADESH, CHINA, COCOS ISLAND, HONG KONG, INDIA, INDONESIA, KOREA, MALAYSIA, PHILIPPINES, SINGAPORE, SOUTH KOREA, SRI LANKA, THAILAND, RUSSIA, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SOUTH AFRICA, NEW CALEDONIA, POLAND, PORTUGAL, QATAR, REUNION,IRAN, ISRAEL, JORDAN, KUWAIT, LATVIA, LEBANON, LUXEMBOURG, MONACO, MOROCCO, JAPAN, ARGENTINA, ARUBA, BAHAMAS, BARBADOS, BELIZE, BERMUDA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EL SALVADOR, FALKLAND ISLANDS, HAITI, HONDURAS, JAMAICA, MEXICO, PANAMA, PERU, TRINIDAD & Tobago, URUGUAY, VENEZUELA, AND NETHERLANDS ANTILLES.
  • Product Description
    LATITUDE¿ Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). || There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the US || The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1. || Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA