Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Wallflex Biliary RX Fully Covered Stent System RMV [UPN: M00570370; GTIN: 08714729953180; Batch: 25607019].
The manufacturer is removing one batch of the Wallflex Biliary RX Fully Covered Stent System RMV product after becoming aware that units from the affected batch were labeled as fully covered 10 x 60mm stents but the package contained 10 x 60mm uncovered stents.
The most common adverse health consequence would be prolonged procedure to remove the stent and exchange the product. The most severe health consequence that is reasonably expected to occur if the uncovered stent attempted to be manipulated or removed after initial placement is perforation, bleeding, tissue abrasion or other patient injury.
The manufacturer recommends users to do the following actions:
Product removal 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 5 August 2020