Crimper Model 9100CR26 The Crimper is indicated for use in preparing… — Class II medical device recall Z-0918-2014
Terminated recall by Edwards Lifesciences, LLC, reported 2014-02-12, distributed nationwide. Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they m
| Recall number | Z-0918-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2014-01-20 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 422 |
| Lot numbers | 59617777, 59658495 |
| Model numbers | 9100CR26 |
Product
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Reason for recall
Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.
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-0918-2014. 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.