Device Recall Riata ST Silicone Insulated Leads

  • Modèle / numéro de série
    Riata ST models (700X, 701X, 704X)
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA