Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
This recall has been terminated (originally issued April 17, 2013).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- March 26, 2013
- Posted
- April 17, 2013
- Terminated
- September 16, 2013
- Recall Number
- Z-1135-2013
- Quantity
- 6,117 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Models 9100CR26, all lot numbers.
Root Cause
Package design/selection
Action Taken
Edwards Lifesciences notified customers via letter and instructed them to maintain the device in its protective unit carton until ready for use and to inspect the pouch for holes or tears prior to use as instructed in the product's labeling. If any holes or tears are found, customers are instructed to contact Edwards Customer Service to arrange for return and replacement of damaged product.