FDA-Device2025-03-19Class II
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
CardioFocus, Inc.
Hazard
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Sold states
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.
Affected count
833 units
Manufactured in
500 Nickerson Rd Ste 500-200, Marlborough, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1307-2025Don't want to check this manually?
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