# FDA recall Z-1307-2025

> **CardioFocus, Inc.** · Class II · device recall initiated 2025-02-07.

## 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

## Reason for recall

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

## Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic,  Italy, Japan, United Kingdom.

## Key facts

- **Recall number:** Z-1307-2025
- **Recalling firm:** CardioFocus, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-07
- **Report date:** 2025-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1307-2025

## Citation

> AI Analytics. FDA recall Z-1307-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1307-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*