Edwards SAPIEN 3 Transcatheter Heart Valve — Class II medical device recall Z-2435-2018
Terminated recall by Edwards Lifesciences, LLC, reported 2018-07-25, distributed in NJ. SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
| Recall number | Z-2435-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2018-06-11 |
| Classified | 2018-07-13 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2019-05-23 |
| Distributed | NJ |
| Quantity | 1 valve |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00690103194357 |
| Serial numbers | 6005731 |
| Model numbers | 9600TFX |
| Expiration dates | 2020-01-24 |
Product
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Reason for recall
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
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-2435-2018. 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.