medical Class II Updated 2018-07-25

Edwards Lifesciences, LLC recalls Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 960

Recalled Product

Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm

Hazard / Issue

SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.

Issued by

FDA

Affected States: NJ
Lot/Code Info: Use By: 2020-01-24, Serial #: 6005731, UDI #: (01)00690103194357(17)200124(21)6005731
View official government recall

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