Device Recall Protege GPS SelfExpanding Nitinol Stent Biliary System

  • Model / Serial
    Lot 1211723, expiration date Nov 2007
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    GA, OK and TX
  • Product Description
    ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and is designed with 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 in the biliary ducts.
  • Manufacturer
  • 1 Event

Manufacturer

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