Medical device manufacturer, Boston Scientific Corporation has issued a medical device safety alert concerning a recall of Vessix Generator System with catalogue number RDNS010 and the following serial numbers:
An investigation has found that the units manufactured since April 2013 were not manufactured according to specification. This manufacturing issue may cause an electrical short in the generator. The recall affects the generator only and does not impact the Vessix Renal Denervation Catheter or other components of the system.
Boston Scientific explains that this issue could result in excessive radiofrequency energy being delivered to the renal artery and subsequently lead to thrombosis formation, nerve damage and thermal damage to the renal artery or adjacent structures.
According to the local supplier, the affected products were not distributed to Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 November 2013