Endologix Announces Limited Voluntary Recall of Powerlink System Delivery Catheter

Endologix, Inc. announced that it is voluntarily conducting a limited product recall of selected Powerlink® System delivery catheters marketed in the U.S., which are used to deliver the Company's minimally invasive treatment for abdominal aortic aneurysms (AAA). This action does not include the Powerlink stent grafts that have been implanted in patients. In addition, it does not include the large diameter 34 mm Powerlink System being evaluated under an investigational device exemption or Powerlink Systems sold outside of the U.S., as both of these Systems utilize a different delivery catheter. Endologix has notified the U.S. Food and Drug Administration (FDA) Los Angeles District Office. The company is initiating this action as a result of its ongoing comprehensive analysis of three recent reports of tip separation from the catheter sheath inner core during procedures. In two of the cases the Powerlink stent graft was successfully deployed and in one case the separation occurred before the device could be positioned for deployment.

For complete FDA report of this update, please refer to: http://www.fda.gov/oc/po/firmrecalls/endologix12_05.html

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