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
    65096
  • Event Risk Class
    Class 2
  • Event Number
    Z-1339-2013
  • Event Initiated Date
    2013-04-10
  • Event Date Posted
    2013-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117878
  • 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 crm is conducting a recall on the latitude patient management system model 6488 version 7.3 because between march 4 and 27, 2013, a siebel release caused ~5000 distributed pmr clinic faxes to display with illegible characters and not the required, patient non-compliance information that was intended.
  • Action
    Boston Scientific CRM Corp began re-faxing the 4,912 previously illegible PMR notifications on April 10, 2013 and completed on April 15, 2013, successfully fulfilling labeling expectations that these notifications be communicated to the clinic. For questions regarding this recall call 651-582-4000.

Device

LATITUDE Patient Management System
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including DC and PR
  • Product Description
    LATITUDE¿ Patient Management System, Model 6488, Version 7.3. || The LATITUDE Patient Management system is 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