FDAFDA · Food and drugs·Recall number Z-2435-2018
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Published July 25, 2018 · Recall initiated: June 11, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- NJ
- Lot
- Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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