Recall Z-1307-2025 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
CardioFocus, Inc.
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
| Date | Mar 10, 2025 (initiated Feb 7, 2025) |
| Status | Open, Classified |
| Reason | Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. |
| Root 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 inv |
| Quantity | 833 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.