Events

Recall of Boston Scientific COGNIS ICD Models N107, P107

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Cardiac Pacemakers 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
    17381
  • Event Initiated Date
    2014-09-18
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Reason
    A subset of cognistm crt-ds and teligentm icds that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (lv) capacitor. with one additional year of clinical experience and analysis, the manufacturer has identified a second subset of devices that may exhibit compromised lv capacitor performance at a rate that is similar to the august 2013 advisory subset.
  • Action
    Manufacturer to issue advice regarding use

Device

Boston Scientific COGNIS ICD Models N107, P107
  • Model / Serial
    Model: Models: N107, P107, Affected: Manufactured prior to March 2010
  • Manufacturer
    Cardiac Pacemakers Inc

Manufacturer

Cardiac Pacemakers Inc
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NZMMDSA