FDA recall Z-2435-2018

Product

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

Reason for recall

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

Distribution

NJ

Key facts

Status

Terminated

Initiation date

2018-06-11

Report date

2018-07-25

Termination date

2019-05-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2435-2018