Device Recall XACT Carotid Stent System

  • Model / Serial
    Lot Number: 9020551
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide: GA, NY, IN, LA, MA and PA
  • Product Description
    Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) || The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number: 9011951
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide: GA, NY, IN, LA, MA and PA
  • Product Description
    Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) || The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.
  • Manufacturer