Medical device manufacturer, Abbott Vascular, has issued a Field Safety Notice concerning the RX Accunet Embolic Protection System.
Abbott Vascular has discovered that certain lots may exhibit difficult removal of the peel away sheath due to a higher than normal wall thickness. There have been no adverse patient effects reported as a result of this issue. This action does not affect patients having successfully undergone endovascular carotid procedures. However, if an affected device is used it may result in difficulty initiating the peel away sheath, possibly resulting in additional device maneuvers and or a delay in procedure. This action does not affect any inventory beyond the units identified here.
According to the local supplier, Hong Kong is NOT affected.
If you are in possession of the affected products, please contact your supplier for necessary actions.