Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Valiant Navion Thoracic Stent Graft System. The affected devices are identified as follow:
The manufacturer is voluntarily recalling specific serial numbers of the Valiant Navion Thoracic Stent Graft Systems distributed in Japan that is not compliant with the current approval. The manufacturer was informed by its supplier that the incorrect medical grade of silicone was used in manufacturing a small number of batches of the flush port seal of the affected products.
The manufacturer's engineering assessment has determined that use of the incorrect medical grade of silicone in the manufacture of the flush port seal does not negatively impact the ability of the affected products to be flushed or maintain hemostasis during the procedure. The manufacturer predicts the use of the incorrect medical grade of silicone will not present an increased risk to patients and procedure per Instructions For Use. The manufacturer has not received any complaints reported related to this issue.
For patients who were treated using an affected product, no additional follow-up is necessary.
Affected users are instructed to identify and quarantine all unused affected product in their inventory. Product recall is on-going.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 February 2020