Brand
CardioFocus, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for CardioFocus, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-19FDA-DeviceClass IICardiFocus 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
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
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