Z-1135-2013Class II

Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve...

Name: Z-1135-2013 Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve...
Creator: Edwards Lifesciences, LLC
Published: 2013-03-26
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-03-26 / Terminated / root cause: packaging

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use on 2013-03-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1135-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-26
Posted: 2013-04-17
Terminated: 2013-09-16
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.
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
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.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Models 9100CR26, all lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1135-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1134-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17
Z-1135-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17

Product code NPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)