Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial Recalled by CardioFocus, Inc. Due to Damage to the sterile barrier pouch of catheter,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CardioFocus, Inc. directly.
Affected 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
Quantity: 833 units
Why Was This Recalled?
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CardioFocus, Inc.
CardioFocus, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report