Events

Recall of TEMPORARY MYOCARDIAL BIPOLAR HEARTWIRE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA 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
    27965
  • Event Risk Class
    II
  • Event Initiated Date
    2012-10-25
  • 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
    Spacing between zig-zag wire and insulation is too long (10mm instead of 2mm). the defects affects the proper placement of zig-zag into the heart wall and subsequent electrical contact might be compromised.

Device

TEMPORARY MYOCARDIAL BIPOLAR HEARTWIRE
  • Model / Serial
    Model Catalog: TME 64-S (Lot serial: C1-07056)
  • Product Description
    TEMPORARY MYOCARDIAL BIPOLAR HEARTWIRE
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC