Events

Recall of ISOLINE 2CR6 and 2CT6 Implantable Defibrillation Leads

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Sorin Group Australia.

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
    RC-2013-RN-00088-2
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00088-2
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    As of december 31, 2012, 30 cases of internal insulation breach under the rv or svc defibrillation coil have been confirmed by the analysis conducted on returned products. in each of the 30 identified cases, the internal insulation breach of the silicone lumen was observed under the rv and/or svc defibrillation coil, i.E. where the microcables are not coated with etfe, resulting in a contact between the conductors, thus leading to low pacing impedance and/or ventricular oversensing, and/or inappropriate therapy. it should be noted that in case of ventricular oversensing, pacing is inhibited.
  • Action
    Sorin Group Australia is issuing a 'Hazard Alert' letter to implanting/ treating clinicians and hospitals detailing the issues and how to manage the affected patients. The TGA has published a web statement regarding the issues. For more information, please see http://www.tga.gov.au/safety/alerts-device-isoline-leads-130306.htm .

Device

ISOLINE 2CR6 and 2CT6 Implantable Defibrillation Leads
  • Model / Serial
    ISOLINE 2CR6 and 2CT6 Implantable Defibrillation LeadsPrevious ARTG numbers (cancelled in Nov 2011) : 165673, 165674Multiple serial numbers
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Sorin Group Australia

Manufacturer

Sorin Group Australia