Events

Recall of Device Recall Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems

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
    76593
  • Event Risk Class
    Class 2
  • Event Number
    Z-1543-2017
  • Event Initiated Date
    2017-02-27
  • Event Date Posted
    2017-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153631
  • 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
    Medtronic is initiating a voluntary urgent medical device recall for a subset of endurant/ endurant ii bifurcated stent graft systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
  • Action
    Medtronic sent an Urgent Medical Device Recall letter dated March 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that your facility has received a potentially affected Endurant /Endurant II 23mm and / or 25mm Bifurcated Stent Graft System from the identified subset. As a result, Medtronic is asking that you take the following actions: Identify and quarantine unused Endurant /Endurant II 23mm and 25mm Bifurcated Stent Graft System from the identified subset of models and serial numbers that are in your inventory . Return unused products from the attached model and serial number list that are in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570 (#4) and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of this product as necessary. Complete the attached Customer Confirmation Certificate and email it to RS.CFQFCA@Medtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For further questions please call Customer Service at 1 (800) 633-8766.

Device

Device Recall Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Argentina Armenia Australia Austria Belgium Brazil Bulgaria Canada China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt El Salvador Finland France French Polynesia Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Mexico Montenegro Netherlands New Zealand Norway Oman Panama Paraguay Peru Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam
  • Product Description
    Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems || Model Numbers: || ETBF2516C145E || ETBF2516C166E || ETBF2316C145E || ETBF2313C145E || ETBF2513C166E || ETBF2313C166E || ETBF2316C166E || ETBF2313C124E || ETBF2513C145E || ETBF2516C124E || ETBF2316C124E || ETBF2513C124E. || Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient's vasculature.
  • 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