Events

Recall of Device Recall LATITUDE Patient Management System Communicator

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
    61107
  • Event Risk Class
    Class 2
  • Event Number
    Z-1135-2012
  • Event Initiated Date
    2012-01-19
  • Event Date Posted
    2012-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107311
  • 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
    One (1) model 6476 latitude communicator is unable to interrogate the patient's pulse generator. boston scientific has determined that this is due to a patient receiving an incorrect communicator. therefore the communicator did not find and was unable to interrogate the assigned patients pg. additionally when the patient attempted to set-up this incorrect communicator, the system reflected.
  • Action
    On January 19, 2012 Boston Scientific telephoned the affected patient and their clinic. The patient was notified that the communicator they received will not be able to activate successfully and that their communicator and sensors would be replaced. The clinician was informed of the patient's communicator was sent incorrectly to the other patient who attempted to activate it, the monitored status of the website was incorrect and that a new communicator would be shipped to the patient that will work with their device.

Device

Device Recall LATITUDE Patient Management System Communicator
  • Model / Serial
    SN 224453
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: UT only.
  • Product Description
    Boston Scientific, LATITUDE¿ Patient Management System Communicator, Models 6476. || 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.
  • 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