Endologix Announces Limited Voluntary Recall of Powerlink System Delivery Catheter
Endologix, Inc. announced today that it is voluntarily recalling selected Powerlink System delivery catheters marketed in the U.S (Powerlink Systems sold outside of the US use a different delivery catheter). These products are used to perform minimally invasive treatment for abdominal aortic aneurysms (AAA). The company decided the recall after analysing three reports of tip separation from the catheter sheath inner core during procedures. during one of them the stent graft could not be put in place (it’s not the stent graft itself which is at fault, it’s the delivery catheter). The AP reported that a spokeman for the company said about 35 to-be-recalled catherers are currently at hospitals out of 350-400 sold this year while the company is testing finished catheters in inventory.
December 14, 2005 Related topics: Quality, Safety, Errors, Cardiology