Recall -- Firm Press Release
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Endologix Announces Limited Voluntary Recall of Powerlink System Delivery Catheter
FOR IMMEDIATE RELEASE -- Irvine, CA -- December 14, 2005 -- Endologix, Inc. today 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 and intends to initiate and rapidly complete this action. Endologix and its regulatory legal counsel have determined this action to be categorized as a Class 2 recall; however, final determination of recall classification is pending FDA review. A class 2 recall is one that involves a product or products that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Endologix 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. Additional engineering and quality evaluations, and testing of existing Powerlink inventory are being completed, and Endologix does not anticipate any interruption in product availability due to this action. Corrective and preventative actions have been identified and will be actively integrated into the manufacturing operations.
"It is important to note that this voluntary recall is due to issues with only the bifurcated delivery catheter used with our Powerlink device, and not with the bifurcated stent graft itself. This voluntary recall is being undertaken as a conservative measure in response to recent reports of tip separation. Based on our analysis, we have already identified opportunities for improvement in the assembly of these selected delivery catheters used with our Powerlink device," said Paul McCormick, President and CEO of Endologix.
"As a responsible medical device company, our focus is aimed at providing safe, effective and reliable delivery of the Powerlink stent graft, with an integrated process of continuous improvement including both corrective and preventative action. I am confident our regulatory and quality team, working closely with the FDA and our marketing and field personnel will effectively complete this action involving an estimated 35 catheters in an organized and efficient manner," he added.
The Company expects to take a one-time charge of approximately $700,000 to $800,000 during the current quarter to account for the product consumed in the evaluation and testing and any additional inventory write down.