Edwards Lifesciences, LLC: Medical Device Recall in 2013 - (Recall #: Z-1135-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 26, 2013

Date Posted: April 24, 2013

Recall Number: Z-1135-2013

Event ID: 64747

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.

Status: Terminated

Product Quantity: 6,117 units

Code Information:

Models 9100CR26, all lot numbers.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated