Events

Recall of HEARTMATE II LVAS - SYSTEM CONTROLLER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ABBOTT MEDICAL CANADA INC..

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
    121776
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    As follow-up to the most recent communication in september 2015we are advising health canada that thoratec corporation acquired by abbott laboratories is updating its alert guides conducting a software upgrade and adding controller alignment markings for the heartmate ii system controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations. the current updates include: - updated labeling and alarm guides which will be provided by an abbott representative and included with the system controller packaging. - a software upgrade that simplifies the system controller alarm messaging by removing some advisory alerts on the patient's system controller. these are non-critical alerts that will be seen by clinicians on the system monitor when patients come in for their next appointment. removing these advisory alerts from the system controller will further reduce the chance that a patient will react to such an alert by attempting to change system controllers unnecessarily. - enhanced connector alignment markings on the system controller and the lvad's driveline connector to provide clearer aids in aligning the connectors during insertion/removal. o the system controller with new yellow markings will be provided to all new patients and those current patients with a replacement of the system controller. o some existing patients will need to have their controller replaced (i.E. damaged or old model controller). in these cases we will replace the controller at no cost however in such a case the patient's implanted driveline will not be changing and will not have matching yellow markings.

Device

HEARTMATE II LVAS - SYSTEM CONTROLLER
  • Model / Serial
    Model Catalog: 106762 (Lot serial: ALL); Model Catalog: 106015 (Lot serial: ALL)
  • Product Description
    HEARTMATE II LVAS-SYSTEM CONTROLLER;HEARTMATE II LVAS-IMPLANT KIT
  • Manufacturer
    ABBOTT MEDICAL CANADA INC.

Manufacturer

ABBOTT MEDICAL CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC