Device evidence

device-recall:cfres:212400

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

Official recall number

Z-1307-2025

Evidence summary

Product code: OAE
Recall status: Open, Classified
Event initiated: February 07, 2025
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1307-2025