Medical device manufacturer, Boston Scientific Ltd, has issued an urgent field safety notice concerning the limited number of batches of the Profile™ Single-Use Pediatric Snare.
The manufacturer has become aware through customer complaints that it may be difficult to fully extend the snare loop from the catheter. As a result, a minor delay to the procedure may occur. According to the manufacturer, no injury is reasonably expected to occur as a result of this issue.
According to the local supplier, the affected batches were not distributed in Hong Kong. For details, please refer to the attached field safety notice. If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 21 May 2012