Device Recall MynxGrip Vascular Closure Device

  • Modelo / Serial
    Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US in the states of CA, and MS.
  • Descripción del producto
    6F/7F MynxGrip Vascular Closure Device; || Product Model MX6721, || Product Usage: || The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    AccessClosure, Inc., A Cardinal Health Company, 5452 Betsy Ross Dr, Santa Clara CA 95054-1101
  • Empresa matriz del fabricante (2017)
  • Source