Device Recall Urethral Warmer System

  • Model / Serial
    GW469, GW470, GW468, GW472
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, including CA, GA, TX and the country of Canada.
  • Product Description
    Urethral Warmer System Model number FPRCH3001 || The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Galil Medical, 4364 Round Lake Road, Arden Hills MN 55112
  • Manufacturer Parent Company (2017)
  • Source
    USFDA