Edwards Lifesciences Crimpers — Class II medical device recall Z-1135-2013
Terminated recall by Edwards Lifesciences, LLC, reported 2013-04-24, distributed nationwide. Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouche
| Recall number | Z-1135-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2013-03-26 |
| Classified | 2013-04-17 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 6,117 units |
| Reason classes | sterility |
| Model numbers | 9100CR26 |
Product
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1135-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.