Events

Recall of Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Cap

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
    66322
  • Event Risk Class
    Class 2
  • Event Number
    Z-0083-2014
  • Event Initiated Date
    2012-09-19
  • Event Date Posted
    2013-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122048
  • 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 graft, aortic aneurysm treatment system - Product Code MIH
  • Reason
    Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by ifu.
  • Action
    A Medical Device Information letter was sent to all affected customers on September 19, 2012. Additionally, all Medtronic Field Representatives were notified of the issue via a Field Memo

Device

Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Cap
  • Model / Serial
    TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Product Description
    Valiant Thoracic Stent Graft with Captivia Delivery System, || Talent Thoracic Stent Graft with the Captivia Delivery System.
  • Manufacturer
    Medtronic Vascular, Inc.

Manufacturer

Medtronic Vascular, Inc.
  • Manufacturer Address
    Medtronic Vascular, Inc., 3850 Brickway Blvd, Santa Rosa CA 95403-8223
  • 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