Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its HANAROSTENT esophagus cover. [Approved number: 22700BZ100034000; product numbers: (1) 2379, (2) 2380, (3) 2381; applicable lots: (1) 16045023, (2) 16045030, 16055012, (3)16045037].
The manufacturer started voluntary recall of the product since there was a possibility that the outer sheath of delivery system of HANAROSTENT was broken.
Since this field action is for the outer sheath of HANARO stent's delivery system. If the outer sheath of HANARO stent's delivery system is damaged inside the patient, there is a possibility that they are unable to deploy the stent properly. If stent deployment issue occurs inside the patient, they may need to take further medical intervention such as removal of the stent, but the probability of serious injury is occasional. According to the manufacturer, there is no risk for the patients that were already implanted with HANARO stents.
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 2 September 2016