FDA-Device2018-07-25Class II
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Edwards Lifesciences, LLC
Hazard
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Sold states
NJ
Affected count
1 Valve
Manufactured in
1 Edwards Way, Irvine, CA, United States
Products
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2435-2018Don't want to check this manually?
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