Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients who endovascular grafts have exhibited migration or endoleak, or are at risk for such complications, in whom augmented radial fixation and or sealing is required or regain or maintain adequate aneurysm exclusion.

It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.

The firm initiated their recall on September 13, 2017, by letter. The letter requested the consignee take the following actions: "1. Identify and quarantine all unused affected product as listed in your inventory. 2. Return all unused affected list product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-854-3570 to initiate a product return and credit. Your local Medtronic Representative can assist you in the return and replacement of this product as necessary. 3. Complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and email to RS.CFQFCA@medtronic .com. This notice needs to be passed on to all those who need to be aware within your organization where the potentially affected devices have been transferred." For further questions, please call (508) 261-8000.