Device Recall Edwards LifeStent FlexStar Biliary Stent System

Manufacturer

  • 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 here

  • 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
  • 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
  • Model / Serial
    Lot Numbers: FR6G0122, (Exp 2008/07), FR6G0123 (Exp 2008/08), FR6H0193 (Exp 2008/08) and FR6H0201 (Exp 2008/08).
  • Product Classification
  • 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
  • Model / Serial
    Lot Numbers: FR6G0124 (Exp 2008/08), FR6G0125 (Exp 2008/07) and FR6H0181 (Exp 2008/08).
  • Product Classification
  • 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
  • Model / Serial
    Lot Numbers: FR6G0126 (Exp 2008/07), FR6G0127 (Exp 2008/08) and FR6H0200 (Exp 2008/08).
  • Product Classification
  • 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
  • Model / Serial
    Lot Number: FR6G0129.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
  • Manufacturer
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