Events

Recall of Medtronic Aptus(TM) HeliFX(TM) Thoracic EndoAnchor(TM) System HeliFX Guide 42 mm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Vascular, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78127
  • Event Risk Class
    Class 2
  • Event Number
    Z-3227-2017
  • Event Initiated Date
    2017-09-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158729
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Endovascular suturing system - Product Code OTD
  • 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.

Device

Medtronic Aptus(TM) HeliFX(TM) Thoracic EndoAnchor(TM) System HeliFX Guide 42 mm
  • Model / Serial
    UDI 00763000006679, Lot Number 0008674156 UDI 00763000006655, Lot Number 0008674157
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.
  • Product 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.
  • Manufacturer
    Medtronic Vascular, Inc.

Manufacturer

Medtronic Vascular, Inc.
  • Manufacturer Address
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA