Events

Recall of ABDOMINAL STENT GRAFT SYSTEM - OVATION PRIME

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTER V MEDICAL 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
    116788
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-23
  • 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
    Rapid emptying of the fill polymer syringe when it is connected to the auto injector during the fill polymer injection step of the primary implant procedure has resulted in incomplete aortic body graft fill transient hypotension response prolonged procedure time and/or failure to exclude the aneurysm.

Device

ABDOMINAL STENT GRAFT SYSTEM - OVATION PRIME
  • Model / Serial
    Model Catalog: TV-AB2980-D (Lot serial: FS031814-11)
  • Product Description
    ABDOMINAL STENT GRAFT SYSTEM-OVATION PRIME
  • Manufacturer
    INTER V MEDICAL INC.

Manufacturer

INTER V MEDICAL INC.
  • Manufacturer Address
    MONTREAL
  • Source
    HC