This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Abbott has issued a letter to affected customers recommending updated instructions when removing the TactiFlex Ablation Catheter, Sensor Enabled from its packaging.
| 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 |
What to Do
Inspect the packaging and catheter for damage or kinking prior to use. To avoid damaging the catheter tip, ensure the distal tip has been fully retracted from the tip protector prior to lifting the distal tip out of the tray.
On September 10, Abbott sent all affected customers a letter recommending the following actions:
- Continue following the product IFU by inspecting the packaging and catheter for damage and/or kinking prior to use.
- Review the guidance in Appendix A (as seen below) for information on proper removal technique of the TactiFlex Ablation Catheter, Sensor Enabled from the packaging tray, ensuring to inspect the electrodes and catheter tip carefully for integrity and overall condition prior to use.
- Please complete the provided Acknowledgement Form with the assistance of your Abbott representative. This form ensures you are aware of the advisory notice and have been given an opportunity to ask questions.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Early Alert
Abbott has become 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 3 recently reported instances where tips have detached and remained in the patient. In all three cases there were no further reported adverse outcomes to the patients. Abbott has made changes to the packaging tray design to reduce the likelihood of tip damage during catheter removal and has recently started to deploy the new packaging.
Tip detachment is most often detectable prior to use, and, if a tip detaches prior to insertion into the patient, the physician should replace the catheter. In the event the tip detaches during the procedure, there is the potential for embolism or migration of the detached material. This can potentially lead to respiratory compromise, hemodynamic instability, stroke, ischemia, cardiac perforation, and/or vascular injury.
As of September 11, Abbott has not reported any serious injuries or deaths associated with this issue.
Device Use
The TactiFlex Ablation Catheter Sensor Enabled is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter, when used in conjunction with a compatible RF generator and three-dimensional mapping system.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abbott at 1-855-478-5833.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
