Marlborough, MA, United States
CardioFocus, Inc. recalls
1 recall recorded since 2018, most recently on 7 February 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 February 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1307-2025
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.