Device Recall Protege GPS

  • Model / Serial
    Lot numbers: 257984, 257985, and 257986.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Eleven (11) devices were distributed to seven (7) U.S. customers. Ten (10) devices were distributed to seven (7) clinical study sites in the U.S.
  • Product Description
    Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary)
  • Manufacturer
    Ev3
  • 1 Event

Manufacturer

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

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot # 672655
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Eleven (11) devices were distributed to seven (7) U.S. customers. Ten (10) devices were distributed to seven (7) clinical study sites in the U.S.
  • Product Description
    Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary)
  • Manufacturer
    Ev3
  • Model / Serial
    Lot 117182
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    FL and PA
  • Product Description
    ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
  • Manufacturer
    Ev3
  • Model / Serial
    1179167
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    FL and PA
  • Product Description
    ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-08-20-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
  • Manufacturer
    Ev3
  • Model / Serial
    1179173
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    FL and PA
  • Product Description
    ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-10-30-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
  • Manufacturer
    Ev3
  • 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
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