Device evidence

device-recall:cfres:143414

CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.

Official recall number

Z-1174-2016

Evidence summary

Product code: DRE
Recall status: Terminated
Event initiated: December 31, 2015
Root cause: Mixed-up of materials/components
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1174-2016