CardiFocus Heartlight X3 Cardiac Catheter Sterile Barrier Damage Recall
CardioFocus is recalling 833 units of CardiFocus Heartlight X3 cardiac catheters due to potential damage to the sterile barrier pouch that could compromise product sterility. Affected units were distributed worldwide.
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide