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Edwards Lifesciences, LLC recalls Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto th
Recalled April 24, 2013 · FDA recall Z-1135-2013 · Edwards Lifesciences
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. · FDA Class II
Units
6,117 units
Sold at
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.
Description
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.
Product
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →