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CardioFocus, Inc. recalls CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in
Recalled March 19, 2025 · FDA recall Z-1307-2025 · CardioFocus
Hazard
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. · FDA Class II
Units
833 units
Sold at
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.
Description
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Product
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
Manufacturer(s)
CardioFocus, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →