Device Recall Edwards LifeStent FlexStar selfexpanding bilary stent system

Model EX080801CD; Lot FR6K0319

Gastroenterology-Urology Devices

2

Yes

Nationwide including states of OK, GA, CA WI, MO, and LA

Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards Lifesciences, LLC., Irvine, CA 92614