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

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

CardioFocus issued via email on 2/7/25 Urgent Field Safety Notice. Letter states reason for recall, health risk and action to take: Please forward the provided field safety notice to all individuals within the organization who need to be made aware. We request you immediately check all stock and operating room storage for affected devices, quarantine and discontinue use of affected devices. Please complete the attached Customer Reply Form and return it at your earliest convenience. Actions to be taken by CardioFocus: CardioFocus will send our team to perform an onsite inspection of your inventory and provide replacement devices for any products identified as damaged. The primary contact for this FSCA is Jenny Xia of CardioFocus. Her phone number is 508-658-7200, her cell phone is (603) 897-5787 and e-mail address is [email protected]. Can be contacted Monday through Friday, from 8 AM ET to 5 PM ET.