Alert on Abbott’s TactiFlex Ablation Catheter

FDA is issuing an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing the TactiFlex Ablation Catheter from its packaging. “Abbott has become aware of tip detachment events during catheter removal from the packaging,” the alert says. “Improper removal from the packaging can result in tip damage.”

The alert notes that although most damaged tips were detected prior to catheter insertion into patients, there have been three recently reported instances where tips have detached and remained in the patient. Abbott has made changes to the packaging tray design to reduce potential tip damage from now on.

The catheter is indicated for use in cardiac electrophysiological mapping and for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, according to the alert.