Device Recall Diamondback 360 Coronary Orbital Artherctomy System

  • Modèle / numéro de série
    107046, 106992, 106993, 106990.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
  • Description du dispositif
    Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. || The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Cardiovascular Systems, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • Société-mère du fabricant (2017)
  • Source