Device Recall GDC 360 Detachable Coil

  • Model / Serial
    Model number: M0033471020SR0; Lot codes: 17074659, 17581672, and 18617200.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.
  • Product Description
    GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil || Sterile; || Model number: M0033471020SR0; || Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients general medical condition are considered by the treating neurosurgical team to be || a) very high risk for management by traditional operative techniques, or || b) inoperable.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Model Number: GDC-18 360 11MM X 30CM; Lot numbers: 17723781, 17735100 and 17818842.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.
  • Product Description
    GDC-18 360 11MM X 30CM Detachable Coil || Sterile; || Model number: M0033471020SR0 || Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms that¿a because of their morphology, their location, or the patients general medical condition are considered by the treating neurosurgical team to be || a) very high risk for management by traditional operative techniques, or || b) inoperable.
  • Manufacturer