Events

Recall of Device Recall EV3 EverFiex" Selfexpanding Peripheral Stent System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ev3, 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
    74276
  • Event Risk Class
    Class 2
  • Event Number
    Z-2048-2016
  • Event Initiated Date
    2016-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147048
  • 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
    Stent, superficial femoral artery - Product Code NIP
  • Reason
    Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two protege everfiex" self-expanding peripheral stent systems, model prb35-08-040- 080, from lot a164580. the size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner pouch and device labels. this potential issue is limited to two everfiex stent system devices from lot a164580 that were repackaged by medtronic and distributed. this does not affect any other medtronic product or implantable devices.
  • Action
    Medtronic sent an "Urgent Medical Device Recall" letter dated May 2016, to all affected customers. The letter described the problem and the product involved in the recall. Consignees were instructed to identify, quarantine and return unused product to Medtronic. Consignees were requested to complete the 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. Customers with questions were instructed to call 651-367-0612. For question regarding this recall call 763-398-7000.

Device

Device Recall EV3 EverFiex" Selfexpanding Peripheral Stent System
  • Model / Serial
    lot: A164580
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to LA and WI.
  • Product Description
    EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. || The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency
  • Manufacturer
    Ev3, Inc.

Manufacturer

Ev3, Inc.
  • Manufacturer Address
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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