Device Recall MynxGrip Vascular Closure Device

  • Modèle / numéro de série
    Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    US in the states of CA, and MS.
  • Description du dispositif
    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


  • Adresse du fabricant
    AccessClosure, Inc., A Cardinal Health Company, 5452 Betsy Ross Dr, Santa Clara CA 95054-1101
  • Société-mère du fabricant (2017)
  • Source