Guidant Endovascular Solutions, Inc.

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.

Gastroenterology-Urology Devices

2

Yes

Nationwide

Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563

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.

Gastroenterology-Urology Devices

2

Yes

Nationwide

Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010564.

All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010565; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.

Gastroenterology-Urology Devices

2

Yes

Nationwide

Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010565.

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.

Gastroenterology-Urology Devices

2

Yes

Nationwide

Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566.

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.

Gastroenterology-Urology Devices

2

Yes

Nationwide

ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part #FG1010567.