Device Recall Riata ST Silicone Insulated Leads

  • 모델명 / 제조번호(시리얼번호)
    Riata ST models (700X, 701X, 704X)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    USA (Nationwide) and worldwide to: Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Italy, Romania, Russia, Netherlands, Norway, Poland, Portugal, Russia, Serbia, Slovakia, Spain, Sweden, Switzerland, The Netherlands, UK, Australia, China, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, New Zealand, Argentina, Brazil, Colombia, Costa Rica, Ecuador, Mexico, Puerto Rico, Uruguay, Egypt, Greece, India, Iran, Israel, Joran, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, South Africa, Turkey, Malta, Cyprus, Iraq, Egypt, Lybia, Yemen, and U.A.E.
  • 제품 설명
    St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 || Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA