Edwards Lifesciences, LLC recalls Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
- Recall date
- June 11, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2435-2018
- FDA classification
- Class II
- Brand / firm
- Edwards Lifesciences, LLC
- Sold / distributed
- NJ
Why it was recalled
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
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