St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Inadequate seal due to lack of adhesive glue
US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0213-2018