Medical device manufacturer, Boston Scientific, has issued an Urgent Field Notice on Wingspan™ Stent System and Gateway™ PTA Balloon Catheter.
The manufacturer has revised the intended use in the Indication for Use of the device. The revised intended use of the device is as follows:
The Wingspan Stent System and Gateway PTA Balloon Catheter indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels >=50% stenosis that are accessible by the system.
According to the local supplier, the affected products have been distributed in Hong Kong. If you are in possession of the product, please contact your supplier for necessary actions.