The United States Food and Drug Administrations (FDA) has issued a safety communication concerning The Onyx Liquid Embolic System, manufactured by ev3.
The FDA notified physicians and patients about the risk of catheter entrapment associated with the use of Onyx. Catheter entrapment happens when the catheter becomes stuck in the implanted Onyx material. Complications of catheter entrapment include migration of the Onyx plug or catheter fragment to other parts of the body, haemorrhage and death.
According to the local supplier, the affected products have been distributed in Hong Kong. For details, please refer to FDA website
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310199.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 3 July 2012