FDA-Device2013-04-24Class II
Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Edwards Lifesciences, LLC
Hazard
Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
Sold states
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.
Affected count
5,472 units
Manufactured in
12050 Lone Peak Pkwy, N/A, Draper, UT, United States
Products
Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1134-2013Don't want to check this manually?
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