Events

Recall of ANASTAFLO INTRAVASCULAR SHUNT

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
    79601
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-14
  • 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
    Through post market surveillance data review edwards lifesciences has identified a potential halth risk to patients undergoing by-pass surgery when an anastaflo intravascular shunt is used. edwards has received twenty-three complaints concerning excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. there have been no reports of injuries in any of these complaints.

Device

ANASTAFLO INTRAVASCULAR SHUNT
  • Model / Serial
    Model Catalog: IVS1512 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS1530 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS2012 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS2512 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS2030 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS2530 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: IVS3030 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ANASTAFLO INTRAVASCULAR SHUNT
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.