BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-3227-2017 · Initiated September 13, 2017

    Recall

    Recall Number
    Z-3227-2017
    Event Number
    78127
    Firm
    Medtronic Vascular, Inc.
    FEI Number
    3001452571
    Product Code
    OTD
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 13, 2017
    Terminated
    May 18, 2020
    Address
    3576 Unocal Pl, Santa Rosa, CA, 95403-1774

    Description

    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.

    Reason

    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.

    Action

    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.

    Distribution

    US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.

    Quantity

    20 units