Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the del

FDA device recall Z-1134-2013 · posted 2013-04-17 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

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.

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.

Root cause

Package design/selection

Status

Terminated

Product code

NPT

Quantity affected

5,472 units

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,

Date initiated

2013-03-26

Date posted

2013-04-17

Date terminated

2013-09-16

Location

Draper, UT