Recall Z-1307-2025— CardioFocus, Inc.
Class II · Ongoing
Class II FDA medical device recall by CardioFocus, Inc., initiated 2025-02-07. FDA's recall record names no specific 510(k) clearance for this event. 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: Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility..
- Recalling firm
- CardioFocus, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-07
- Firm location
- Marlborough, MA, United States
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
Reason for recall
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.