Device Recall Penumbra 3D Revascularization Device

  • Modelo / Serial
    Lots C00644, C00645, C00646, C00717
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV
  • Descripción del producto
    Penumbra 3D Revascularization Device || It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Penumbra Inc., 1 Penumbra, Alameda CA 94502-7610
  • Empresa matriz del fabricante (2017)
  • Source