ELGX halted. Company announcing limited recall of Powerlink
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Endologix, Inc. (NASDAQ: ELGX) 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. 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 FDA Los Angeles District Office and intends to initiate and rapidly complete this action.
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.
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.
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