Medical device manufacturer, Edwards Lifesciences LLC, has issued a medical device safety alert concerning its Miller Balloon (model 830515F) and Fogarty Dilation (model 830705F) Atrioseptostomy Catheters [Lot Number: All lot within 15-month expiry]
According to the manufacturer, it has identified a potential risk, which may occur during the use of the Miller and Fogarty atrioseptostomy catheters. While the Instructions for Use detail the preparation for use of the product, including inflation and deflation of the balloon to verify functionality, the manufacturer have received reports regarding difficulty in balloon deflation after deployment, and reports of balloon fragmentation or detachment, which has the potential to lead to additional complications.
Product recall is on-going.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 22 March 2019