Devices

Device Recall Aortic cannula

  • Model / Serial
    Model EX24D, Lot No.: 58174875
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CA, CO, FL, GA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OR, PA, RI, TN, TX, VA, WA, and WI. No foreign, military or government distribution.
  • Product Description
    EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
  • Manufacturer
    Edwards Lifesciences Research Medical Inc
  • 1 Event

Manufacturer

Edwards Lifesciences Research Medical Inc
  • Manufacturer Address
    Edwards Lifesciences Research Medical Inc, 6864 South 300 West, Midvale UT 84047-1083
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Aortic Cannula
  • Model / Serial
    Lot Number: 58946275
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA only.
  • Product Description
    Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
  • Manufacturer
    Edwards Lifesciences Llc