Class II — CardioFocus, Inc.
| Recalling firm | CARDIOFOCUS, INC. |
|---|---|
| Registered facility | CARDIOFOCUS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. |
| 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 |
| Quantity | 833 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom. |
| Initiated | 2025-02-07 |
| Classified | 2025-03-10 |
| Recall number | Z-1307-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CardioFocus, Inc. (Z-1307-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96239/
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