Devices

Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent System

Manufacturer

Guidant Endovascular Solutions, Inc.
  • Manufacturer Address
    Guidant Endovascular Solutions, Inc., 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent System
  • Model / Serial
    All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010563; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563
  • Manufacturer
    Guidant Endovascular Solutions, Inc.
Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent System
  • Model / Serial
    All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010564; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010564.
  • Manufacturer
    Guidant Endovascular Solutions, Inc.
Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent System
  • Model / Serial
    All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010566; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566.
  • Manufacturer
    Guidant Endovascular Solutions, Inc.
Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent System
  • Model / Serial
    All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010567; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part #FG1010567.
  • Manufacturer
    Guidant Endovascular Solutions, Inc.
Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent System
  • Model / Serial
    All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010568; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010568.
  • Manufacturer
    Guidant Endovascular Solutions, Inc.