Tuesday, December 20, 2005

Voluntary Product Recall of Selected Powerlink System Delivery Catheters

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Endologix and FDA notified healthcare professionals of the voluntary product recall of selected Powerlink System delivery catheters marketed in the U.S.,used to deliver minimally invasive treatment for abdominal aortic aneurysms.Endologix initiated the recall as a result of an analysis of three recentreports of tip separation from the catheter sheath inner core duringprocedures. This action does not include the Powerlink stent grafts thathave been implanted in patients or the large diameter 34 mm Powerlink Systembeing evaluated under an investigational device exemption or PowerlinkSystems sold outside of the U.S.

Read the complete MedWatch 2005 Safety summary, including a link to thefirm's press release, at: http://www.fda.gov/medwatch/safety/2005/safety05.htm#Powerlink