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Devices
Device Recall Edwards LifeStent FlexStar Biliary Stent System
Model / Serial
Lot Number: FR6H0161
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution
Product Description
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100801CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Manufacturer
Edwards Lifesciences, Llc
1 Event
Recall of Device Recall Edwards LifeStent FlexStar Biliary Stent System
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Manufacturer
Edwards Lifesciences, Llc
Manufacturer Address
Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
Source
USFDA
50 devices with a similar name
Learn more about the data
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Device Recall Edwards LifeStent FlexStar Biliary Stent System
Model / Serial
Lot Numbers: FR6F0111 (Exp 2008/06), FR6G0120 (Exp 2008/08), FR6G0121 (Exp 2008/08), FR6H0135 (Exp 2008/08), FR6H0182 (Exp 2008/08) and FR6H0192 (Exp 2008/08)
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution
Product Description
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Manufacturer
Edwards Lifesciences, Llc
Device Recall Edwards LifeStent FlexStar Biliary Stent System
Model / Serial
Lot Numbers: FR6G0118 (2008/07), FR6G0119 (2008/08), FR6H0137 (Exp 2008/08), FR6H0194 (Exp 2008/08) and FR6H0203 (Exp 2008/08)
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution
Product Description
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Manufacturer
Edwards Lifesciences, Llc
Device Recall Edwards LifeStent FlexStar Biliary Stent System
Model / Serial
Lot Numbers: FR6G0122, (Exp 2008/07), FR6G0123 (Exp 2008/08), FR6H0193 (Exp 2008/08) and FR6H0201 (Exp 2008/08).
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution
Product Description
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060803CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Manufacturer
Edwards Lifesciences, Llc
Device Recall Edwards LifeStent FlexStar Biliary Stent System
Model / Serial
Lot Numbers: FR6G0124 (Exp 2008/08), FR6G0125 (Exp 2008/07) and FR6H0181 (Exp 2008/08).
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution
Product Description
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Manufacturer
Edwards Lifesciences, Llc
Device Recall Edwards LifeStent FlexStar Biliary Stent System
Model / Serial
Lot Numbers: FR6G0126 (Exp 2008/07), FR6G0127 (Exp 2008/08) and FR6H0200 (Exp 2008/08).
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution
Product Description
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Manufacturer
Edwards Lifesciences, Llc
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