Z-2435-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- June 11, 2018
- Termination Date
- May 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 Valve
Product Description
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.
Distribution Pattern
NJ
Code Information
Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731