Class II

Medical Device Recall: 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: 18-50

CardioFocus, Inc. · February 7, 2025

Reason for Recall

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

Product Description

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

833 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1307-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

CardioFocus, Inc. Medical Device Recall: 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: 18-50 | SafeCheck