Events

Recall of Device Recall Talent Thoracic Stent Graft System

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
    61278
  • Event Risk Class
    Class 2
  • Event Number
    Z-1284-2012
  • Event Initiated Date
    2012-02-21
  • Event Date Posted
    2012-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107703
  • 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
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Reason
    Complaints received related to the inability/difficulty to release the proximal (freeflow) bare stent using the tip capture mechanism.
  • Action
    Medtronic, Inc. sent an Urgent Medical Device Safety Information letter dated February 2012, to all affected customers. The letter identified the product, the problem, and the corrective action taken by Medtronic. Medtronic updated the Instructions for Use (IFU) manual. For questions regarding this recall call 707-566-1110.

Device

Device Recall Talent Thoracic Stent Graft System
  • Model / Serial
    TB2222C116CP, TF2424C116CP, TF2626C116CP, TF2828C116CP, TF3030C115CP, TF3232C115CP, TF3434C115CP, TF3636C114CP, TF3838C114CP, TF4040C114CP, TF4242C113CP, TF4444C113CP,  TF4646C112CP, TB2222C161CP, TF2424C161CP, TF2626C161CP, TF2828C161CP, TF3030C160CP, TF3232C160CP, TF3434C160CP, TF3636C159CP; TF3838C159CP, TF4040C159CP, TF4242C158CP, TF4444C158CP, TF4646C157CP, TB2222C201CP, TF2424C201CP, TF2626C201CP, TF2828C201CP, TF3030C200CP, TF3232C200CP, TF3434C200CP, TF3636C199CP, TF3838C199CP, TF4040C199CP, TF4242C198CP, TF4444C198CP, TF4646C197CP.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Talent Captivia Stent Graft System - FreeFlow configurations only. || Model numbers affected have the following designation: || TFXXXXXXXXCP and TBXXXXXXXXCP. || Medtronic Inc. || Santa Rosa, CA 95403. || The Talent¿ Thoracic Stent Graft System is designed to treat thoracic aortic aneurysms using an endovascular approach. When placed within the target lesion, the stent graft provides an alternative conduit for blood flow within a patients vasculature by excluding the lesion from blood flow and pressure.
  • 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