CardioFocus, Inc. is recalling 833 units of the Heartlight X3 Catheter (Model 18-5000), a device used in clinical settings to treat atrial fibrillation. This recall was initiated due to potential damage to the catheter's sterile barrier pouch, which could compromise the sterility of the device. Although no injuries or incidents have been reported, using a non-sterile device in a cardiac procedure can lead to serious health complications for patients. These devices were distributed worldwide to hospitals and medical laboratories between January 2024 and January 2025.
Damage to the sterile barrier pouch of the catheter can lead to contamination of the device. If used during a medical procedure, a non-sterile catheter can introduce bacteria or other pathogens directly into the patient's bloodstream, potentially causing serious infection or other life-threatening complications.
Intended for treatment of atrial fibrillation.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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