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
Reported: March 19, 2025 Initiated: February 7, 2025 #Z-1307-2025
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.
Details
- Recalling Firm
- CardioFocus, Inc.
- Units Affected
- 833 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, Italy, Japan, United Kingdom.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by CardioFocus, Inc.. Units affected: 833 units.
Why was this product recalled? ▼
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2025. Severity: Moderate. Recall number: Z-1307-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11