The FDA today issued a notice warning of updated instructions for the Abbott (NYSE: ABT) TactiFlex Ablation Catheter, Sensor-Enabled (SE).
According to the agency, Abbott issued a letter to affected customers recommending updated instructions when removing the catheter from its packaging. The communication comes as part of the FDA’s Communications Pilot to Enhance the Medical Device Recall Program, with the agency becoming aware of a potentially high-risk issue.
Abbott designed TactiFlex for use in cardiac electrophysiological mapping. It treats drug-refractory recurrent symptomatic paroxysmal AFib and concomitant atrial flutter when used in conjunction with a compatible radiofrequency generator and 3D mapping system.
The company received FDA approval for the catheter in 2023. At the time, it described it as the world’s first ablation catheter with a flexible tip and contact force technology.
TactiFlex also integrates with Abbott’s EnSite X EP System, enabling physicians to visualize heart anatomy more precisely. It can deliver a reduction in procedure times and improved safety compared with the company’s previous-generation ablation catheters.
More about the Abbott catheter warning
Abbott now says it became aware of tip detachment events during catheter removal from the packaging. Improper removal from the packaging can result in tip damage. While most damaged tips were detected prior to catheter insertion into patients, there have been three recently reported instances where tips detached and remained in the patient. In all three cases, the company reports no further adverse outcomes to the patients.
With the issue identified, Abbott made changes to the packaging tray design to reduce the likelihood of tip damage. It recently started to deploy the new packaging, according to the FDA notice.
Abbott said that physicians can most often detect tip detachment prior to use. If a tip detaches prior to insertion, the physician should replace the catheter. In the event the tip detaches during the procedure, the potential exists for embolism or migration of the detached material.
Such an instance would lead to respiratory compromise, hemodynamic instability, stroke, ischemia, cardiac perforation and/or vascular injury.
As of Sept. 11, Abbott reports no serious injuries or deaths associated with the issue.
Customers should inspect the packaging and catheter for damage or kinking prior to use. To avoid damaging the tip, they should ensure the distal tip has been fully retracted from the tip protector prior to lifting the distal tip out of the tray.
Affected devices
| Device Name | Model Number | UDI-DI |
|---|---|---|
| TactiFlex SE Uni-Directional Curve D | A-TFSE-D | 05415067034656 |
| TactiFlex SE Uni-Directional Curve F | A-TFSE-F | 05415067034670 |
| TactiFlex SE Bi-Directional Curve F-J | A-TFSE-FJ | 05415067034618 |
| TactiFlex SE Bi-Directional Curve D-F | A-TFSE-DF | 05415067034571 |
| TactiFlex SE Bi-Directional Curve D-D | A-TFSE-DD | 05415067034557 |
