CardioFocus, Inc.: Device Recall
Recall #Z-1307-2025 · 02/07/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1307-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- CardioFocus, Inc.
- Status
- Ongoing
- Date Initiated
- 02/07/2025
- Location
- Marlborough, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 833 units
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 Pattern
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.