Absolute .035 Self-Expanding Biliary Stent System

• 5 recalls, same reason

  • Terminated Z-1080-06 FDA Unclassified (pre-2012) ·initiated 22 Mar 2006
  • Terminated Z-1083-06 FDA Unclassified (pre-2012) ·initiated 22 Mar 2006
  • Terminated Z-1084-06 FDA Unclassified (pre-2012) ·initiated 22 Mar 2006
  • Terminated Z-1082-06 FDA Unclassified (pre-2012) ·initiated 22 Mar 2006
  • Terminated Z-1085-06 FDA Unclassified (pre-2012) ·initiated 22 Mar 2006

  Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action.

510(k) Number

K033393 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

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