Device product
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Z-2435-2018
Product summary
- Event
- Event 80394
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 Valve
- Official record key
device-enforcement:Z-2435-2018
Official wording
Reason: SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Code information: Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
Distribution pattern: NJ
Derived failure modes
-
Unknown
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.