Devices

Device Recall Edwards Lifesciences Crimpers

  • Model / Serial
    Models 9100CR23, all lot numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
  • Product Description
    Edwards Lifesciences Crimpers, Model 9100CR23. || The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
  • Manufacturer
    Edwards Lifesciences, LLC
  • 1 Event

Manufacturer

Edwards Lifesciences, LLC
  • Manufacturer Address
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Manufacturer Parent Company (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Edwards Lifesciences Crimpers
  • Model / Serial
    Models 9100CR26, all lot numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
  • Product Description
    Edwards Lifesciences Crimpers, Model 9100CR26. || The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
  • Manufacturer
    Edwards Lifesciences, LLC