Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Agile Biliary RX Fully Covered Stent System. The products are identified as follow:

• Material Number (UPN): A) M00586000; B) M00586010; C) M00586020; D) M00586060; E) M00586070; F) M00586080
• GTIN: A) 08714729950202; B) 08714729950219; C) 08714729950226; D) 08714729950264; E) 08714729950271; F) 08714729950288
• Batch Number: All

The manufacturer is conducting a medical device recall of the Agile Biliary RX Fully Covered Stent System.

According to the manufacturer, it becomes aware of situations where the stent has migrated requiring additional intervention and re-stenting due to lack of stricture resolution. The manufacturer does not recommend removal of already implanted devices which are performing adequately.

Based on the higher than anticipated incidence of stent migrations, the manufacturer is withdrawing the affected products from the market. The affected customers are advised to take the following actions:

• Continue to monitor their patients according to standard care;
• Identify any affected product within their inventory and segregate the product immediately;
• Use and distribution of any remaining unused affected products should cease immediately.

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 products, please contact your supplier for necessary actions.

Posted on 31 January 2019