Edwards Lifesciences, LLC: Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

Recall number

Z-1135-2013

Recalling firm

Edwards Lifesciences, LLC

Product

Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

Status

Terminated

Initiated

2013-03-26

Posted

2013-04-17

Terminated

2013-09-16

Reason

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.

Root cause

Package design/selection

Action

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.

Quantity

6,117 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, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.

Lot, serial or model codes

Models 9100CR26, all lot numbers.

510(k) numbers

not on file

PMA numbers

["P100041","P110021"]

Product code

NPT

Firm FEI

1713910

Firm city

Draper

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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