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U.S. Department of Health and Human Services

Safety

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Endologix Powerlink System Delivery Catheters

Audience: Vascular surgery healthcare professionals, OR managers, and hospital risk managers

[Posted 12/20/2005] 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 recent reports of tip separation from the catheter sheath inner core during procedures. This action does not include the Powerlink stent grafts that have been implanted in patients or the large diameter 34 mm Powerlink System being evaluated under an investigational device exemption or Powerlink Systems sold outside of the U.S.

[December 14, 2005 - Press Release - Endologix]