Events

Recall of ASCENDRA 2 DELIVERY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by EDWARDS LIFESCIENCES (CANADA) INC..

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
    28669
  • Event Risk Class
    II
  • Event Initiated Date
    2011-01-14
  • 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
    Edwards lifesciences is issuing a field safety notice to augment the instructions for use of the device to reinforce the correct preparation orientation and hydration of the transcatheter heart valve (thv) when it is loaded onto the ascendra 2 delivery system. edwards lifesciences has become aware that loading at an angle (ie non-coaxial) may unseat the valve within the loader creating a leak path at the seal button. when the valve in the loader is hydrated per the ifu this leakage is likely to be detected before use. if observed leakage can be easily resolved by manipulation of the seal buttons.

Device

ASCENDRA 2 DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: 9320AS23 (Lot serial: N/A); Model Catalog: 9320AS26 (Lot serial: N/A)
  • Product Description
    ASCENDRA 2 DELIVERY SYSTEM
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.