Class 2 Device Recall CardioFocus HeartLight X3 Catheter with Excalibur Balloonc

• Date Initiated by Firm: February 07, 2025
• Date Posted: March 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1307-2025
• Recall Event ID: 96239
• PMA Number: P150026
• Product Classification: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
• 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
• Code Information: UDI-DI: 00859373007433 Serial Numbers: 2315001 2315002 2315003 2315004 2315005 2315006 2315007 2315008 2315009 2315010 2315011 2315012 2315013 2315014 2315015 2315016 2315017 2315018 2315019 2315020 2315501 2315502 2315503 2315504 2315505 2315506 2315507 2315508 2315509 2315510 2315511 2315512 2315513 2315514 2315515 2315516 2315517 2315518 2315519 2317001 2317002 2317003 2317004 2317005 2317006 2317007 2317008 2317009 2317010 2317011 2317012 2317013 2317014 2317015 2317016 2320501 2320502 2320503 2320504 2320505 2320506 2320507 2320508 2320509 2320510 2320511 2320512 2320513 2320514 2320515 2320516 2320517 2320518 2320519 2320520 2323001 2323002 2323003 2323004 2323005 2323006 2323007 2323008 2323009 2323010 2323101 2323102 2323103 2323104 2323105 2323106 2323107 2323108 2323109 2323110 2325001 2325002 2325003 2325004 2325005 2325006 2325007 2325008 2325009 2325010 2325011 2325012 2325013 2325014 2325015 2327201 2327202 2327203 2327204 2327205 2327206 2327207 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• Recalling Firm/ Manufacturer: CardioFocus, Inc.; 500 Nickerson Rd Ste 500-200; Marlborough MA 01752-4698
• For Additional Information Contact: SAME; 508-658-7200
• Manufacturer Reason for Recall: Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
• FDA Determined Cause: Process control
• Action: 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 jxia@cardiofocus.com. Can be contacted Monday through Friday, from 8 AM ET to 5 PM ET.
• Quantity in Commerce: 833 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = OAE