The FDA has posted 6 enforcement recalls of for treatment of atrial fibrillation cardiac ablation percutaneous catheter devices since 2025, including 5 Class I (most serious) recalls. Most recent report: Oct 22, 2025.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation”). Informational only — verify against the FDA before acting.