TactiFlex™ Ablation Catheter, Sensor Enabled™

Issue

Abbott is issuing this recall letter related to the TactiFlex™ Ablation Catheter, Sensor Enabled™. As part of their postmarket surveillance and monitoring processes, Abbott became aware of a limited number of tip detachment events during catheter removal from the packaging. Although the packaging has not changed since the introduction of the device (2022), improper removal from the packaging can result in tip damage. While most damaged tips (26 out of 29 instances) were detected prior to catheter insertion into patients, Abbott has experienced 3 recent instances where tips have detached and remained in the patient (incidence rate of <1:100,000). In all three (3) cases there were no further adverse outcomes reported to the patients. Abbott has made changes to the packaging tray design to help mitigate tip damage during catheter removal and has recently started to deploy the new packaging.