Z-2435-2018 Class II Terminated
FDA device recall Z-2435-2018 was initiated by Edwards Lifesciences, LLC on Jun 11, 2018 and is designated Class II. Reason for recall: SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. The recall status is terminated (terminated May 23, 2019). Affected quantity: 1 Valve.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 25, 2018
- Initiation Date
- Jun 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2435-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026