Devices

Device Recall Edwards LifeStent FlexStar selfexpanding bilary stent system

Model / Serial
Model EX080801CD; Lot FR6K0319
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide including states of OK, GA, CA WI, MO, and LA
Product Description
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
Manufacturer
Edwards Lifesciences, Llc
1 Event
- Recall of Device Recall Edwards LifeStent FlexStar selfexpanding bilary stent system

Manufacturer

Edwards Lifesciences, Llc

Manufacturer Address
Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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