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Edwards Lifesciences, LLC recalls Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Recalled July 25, 2018 · FDA recall Z-2435-2018 · Edwards Lifesciences
Hazard
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. · FDA Class II
Units
1 Valve
Sold at
NJ
Description
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
Product
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →