fda
2 records
FDA Recall: CardioFocus, Inc. — Class II
20250319
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. | Product: CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It i...
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FDA Device Recall: CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillat
2025-03-19
Class II — Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
View Source
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