Medical device manufacturer, Boston Scientific Corporation has issued a medical device safety alert concerning certain lots of 13F/15F Navigator HD Ureteral Access Sheath Set with catalogue numbers 250-227, 250-228 and 250-229.
Boston Scientific has received reports from the field where the tip of the dilator has separated from the body of the dilator. To date, Boston Scientific has received 5 related complaints.
Boston Scientific expects the most common adverse health consequence of this problem would be a secondary intervention to remove the tip of the dilator.
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 7 November 2013