Dive Brief:
- The Food and Drug Administration has published an early alert about risks posed by Abbott’s Tactiflex Ablation Catheter.
- Officials published the alert Thursday in response to Abbott writing to customers. The company updated its instructions after reviewing three reports of catheter tips detaching in patients.
- Abbott had not received any reports of serious injuries or deaths as of Sept. 11. However, the potential for harm led the FDA to class the safety action as a potentially high-risk issue.
Dive Insight:
Physicians use Tactiflex Ablation Catheters to treat atrial fibrillation. The device consists of a long, flexible wire with a metal electrode at its tip.
Abbott wrote to customers about the catheter last week. The company said the device’s packaging is unchanged since it introduced the catheter internationally in 2022. However, Abbott has discovered that people can damage the tip of the catheter when removing the device from the packaging.
The company has received 29 reports of damaged tips. Typically, the damage was detected before the device was used. In three cases, the damaged catheters were used and the tip came off in the patient. No further adverse outcomes were seen in the patients after the tips detached. Still, Abbott said the fault could lead to migration of the detached material, which can lead to respiratory compromise, hemodynamic instability, stroke or ischemia.
In response, Abbott has changed its packaging tray design and updated its instructions for use to reduce the risk of tip damage. The company has provided a series of annotated photographs showing the proper technique for removing the device from its packaging.
Abbott is working to expand the Tactiflex product line. The company began a clinical trial of its Tactiflex Duo Ablation Catheter around one year ago. Abbott designed the catheter to deliver both pulsed field ablation and radiofrequency energy. On an earnings call in July, Abbott CEO Robert Ford said the company had completed enrollment ahead of schedule and was targeting a 2026 international launch.
