Events

Safety Alert for bipolar temporary myocardial heartwire

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Oscor Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-11-28
  • Event Date Posted
    2012-11-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121128.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: oscor bipolar temporary myocardial heartwire the health canada has posted a medical device safety alert concerning bipolar temporary myocardial heartwire (model no.: tme 64-s; lot/serial no.: c1-07056) manufactured by oscor inc. according to the health canada, spacing between zig-zag wire and insulation is too long (10mm instead of 2mm). the defect affects the proper placement of zig-zag into the heart wall and subsequent electrical contact might be compromised. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_oct-dec_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 28 november 2012.

Device

bipolar temporary myocardial heartwire
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Oscor Bipolar Temporary Myocardial Heartwire
  • Manufacturer
    Oscor Inc

Manufacturer

Oscor Inc