Events

Recall of ANACONDA STENT GRAFT SYSTEM - ONE-LOK BIFURCATE BODY WITH DELIVERY

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
    23038
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-06
  • 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
    The manufacturer is updating and consolidating the instructions for use (ifu) for the listed products. included is a new bailout procedure for snapped/broken release wires in the anaconda stent graft system ifu and a new caution in the deployment instructions for the anaconda aaa stent graft system aortic cuff. in addition three current ifus/ifu supplements for the anaconda one-lok aaa stent graft system anaconda iliac stent graft system and anaconda aaa stent graft system aortic cuff have been combined into one main ifu (part no. 301-179).

Device

ANACONDA STENT GRAFT SYSTEM - ONE-LOK BIFURCATE BODY WITH DELIVERY
  • Model / Serial
    Model Catalog: OLB23 (Lot serial: ALL LOTS); Model Catalog: OLB25 (Lot serial: ALL LOTS); Model Catalog: OLB28 (Lot serial: ALL LOTS); Model Catalog: OLB32 (Lot serial: ALL LOTS); Model Catalog: L12X160 (Lot serial: ALL LOTS); Model Catalog: TL1210X080 (Lot serial: ALL LOTS); Model Catalog: L12 X 120 (Lot serial: ALL LOTS); Model Catalog: L12 X 100 (Lot serial: ALL LOTS); Model Catalog: L12 X 080 (Lot serial: ALL LOTS); Model Catalog: L12 X 060 (Lot serial: ALL LOTS); Model Catalog: L17X120 (Lot serial: ALL LOTS); Model Catalog: L16X140 (Lot serial: ALL LOTS); Model Catalog: L16X120 (Lot serial: ALL LOTS); Model Catalog: L15X080 (Lot serial: ALL LOTS); Model Catalog: L13X140 (Lot serial: ALL LOTS); Model Catalog: L13X120 (Lot serial: ALL LOTS); Model Catalog: L13X060 (Lot serial: ALL LOTS); Model Catalog: L12X140 (Lot serial: ALL LOTS); Model Catalog: L12X120 (Lot serial: ALL LOTS); Model Catalog: L12X100 (Lot serial: ALL LOTS); Model Catalog: L12X080 (Lot serial: ALL LOTS); Model Catalog: L12X060 (Lot seria
  • Product Description
    ANACONDA STENT GRAFT SYSTEM ONE-LOK BIFURCATE BODY;ANACONDA STENT GRAFT SYSTEM ILIAC LEG;ANACONDA STENT GRAFT FLARED AND TAPERED LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR);ANACONDA STENT GRAFT ILIAC LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR);ANACONDA STENT GR
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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