CardioFocus, Inc. recalls CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in…

Recall date

February 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1307-2025

FDA classification

Class II

Brand / firm

CardioFocus, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.

Why it was recalled

Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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