Class II — Edwards Lifesciences, LLC
| Recalling firm | Edwards Lifesciences LLC |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation. |
| Quantity | 422 |
| Distribution | Nationwide Distribution |
| Initiated | 2014-01-20 |
| Classified | 2014-02-03 |
| Terminated | 2014-03-24 |
| Recall number | Z-0918-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Edwards Lifesciences, LLC (Z-0918-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67362/
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