FDA Issues Early Alert on Abbott’s Tactiflex Ablation Catheter Tip Detachment

The U.S. Food and Drug Administration (FDA) has issued an early safety alert regarding Abbott’s Tactiflex Ablation Catheter after three reports of catheter tips detaching during procedures. The device, used to treat atrial fibrillation, consists of a flexible wire with a metal electrode at its tip. No serious injuries or deaths have been reported, but the FDA classified the issue as potentially high-risk due to the possibility of complications such as stroke, ischemia, or respiratory compromise.

Abbott received 29 reports of damaged tips, typically identified before use. In three cases, damaged catheters were used, and the tips detached in patients without further adverse outcomes. Investigation revealed that tip damage can occur when removing the device from its packaging. Abbott has revised the packaging tray design, updated instructions for use, and provided annotated photographs to ensure safe handling. The company is also expanding the Tactiflex line, including the Tactiflex Duo Ablation Catheter, which delivers pulsed field and radiofrequency energy.

19-09-2025