FDA Device recall Z-2435-2018
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
- FDA Device
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm by Edwards Lifesciences, citing SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2435-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-11 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Edwards Lifesciences |
| Distribution | NJ |
Product
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Reason
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Identifiers
| code_info | Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2435-2018%22
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