Events

Recall of ISOLINE 2CR DEFIBRILLATION LEAD

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
    27086
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-31
  • 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 of december 31 2012 sorin has confirmed 30 instances out of 13500 units implanted worldwide (0.222%) where the analysis of the returned leads identified internal insulation breach under the right ventricular (rv) and/or superior vena cava (svc) defibrillation coil electrode resulting in low pacing impedance and/or ventricular oversensing and/or inappropriate therapies. no permanent serious injury or death has been reported as a result of the confirmed malfunction.

Device

ISOLINE 2CR DEFIBRILLATION LEAD
  • Model / Serial
    Model Catalog: 2CR-6 (Lot serial: >10 NUMBERS CONTACT COMPANY); Model Catalog: 2CR-5 (Lot serial: >10 NUMBERS CONTACT COMPANY); Model Catalog: 2CT-6 (Lot serial: S2CT604894); Model Catalog: 2CT-6 (Lot serial: S2CT605015); Model Catalog: 2CT-6 (Lot serial: S2CT604781); Model Catalog: 2CT-6 (Lot serial: S2CT604782); Model Catalog: 2CT-6 (Lot serial: S2CT604780)
  • Product Description
    ISOLINE 2CR DEFIBRILLATION LEAD
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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