Events

Recall of LATITUDE

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
    53322
  • Event Risk Class
    Class 2
  • Event Number
    Z-1631-2010
  • Event Initiated Date
    2009-09-10
  • Event Date Posted
    2010-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85269
  • 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 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.

Device

LATITUDE
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    All States in the US including Puerto Rico United Kingdom, Switzerland, Netherlands, Italy, Germany, France, Finland, Denmark, Belgium, Austria
  • Product Description
    Boston Scientific, LATITUDE¿ Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)
  • 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