Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning Ultraflex Tracheobronchial Covered Distal Release Stent System [Material number: M00576550; Lot number: 18876596; Expiration date range: 1 February 2018].
The manufacturer has become aware that the incorrect stent size has been packaged in a single lot of Ultraflex Tracheobronchial Covered Distal Release Stents labeled with 12mm Outer Diameter.
The use of an undersized diameter stent may increase the risk of stent migration in a stent that is not intended to be removed. If the stent were to migrate the tracheobronchial stricture may not be effectively dilated and the patient may experience coughing, difficulty breathing and tissue damage. In addition, the removal of the migrated stent may require an additional procedure.
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 22 March 2016