FDA Device recall Z-1135-2013
Edwards Lifesciences Crimpers, Model 9100CR26
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Edwards Lifesciences Crimpers, Model 9100CR26 by Edwards Lifesciences, citing 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 cust….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1135-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-26 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
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.
Identifiers
| code_info | Models 9100CR26, all lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1135-2013%22
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