CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1307-2025