Events

Recall of Device Recall 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
    57744
  • Event Risk Class
    Class 2
  • Event Number
    Z-2052-2011
  • Event Initiated Date
    2011-01-10
  • Event Date Posted
    2011-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97300
  • 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
    Boston scientific has determined that data within certain printed reports obtained from the latitude patient management system may not be accurate, in that, the most recent presenting electrogram (mrp-egm) for some of the selected patients may be either missing or incorrect.
  • Action
    Consignees were sent a Boston Scientific "LATITUDE¿ Medical Records Information" letter dated January 2011. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also included the Rate of Occurrence, Action and Further Information sections.

Device

Device Recall LATITUDE Patient Management System
  • Model / Serial
    Software Versions 6.x versions launched on June 6, 2010 or later.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including DC and PR, and countries of AUSTRALIA, CANADA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
  • Product Description
    Boston Scientific's LATITUDE Patient Management System: || LATITUDE 6.1 Patient Management System Website || Server software, Model 6488 for United States || Server software, Model 6465 for European Union || LATITUDE 6.2 Patient Management System Website || Server software, Model 6441 for Canada || Server software, Model 6442 for Australia / New Zealand || Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
  • 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