Recall Z-0113-2026 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Abbott
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
| Date | Oct 10, 2025 (initiated Sep 10, 2025) |
| Status | Open, Classified |
| Reason | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| Root cause | Package design/selection |
| Action | Abbott issued a Medical Device Advisory to its consignees on 09/10/2025 by letter delivered via Federal Express. The notice explained the issue, impact and associated risk to the patient and requested the following: "Action Requested/Recommendations/Next Steps . 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 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 fo |
| Quantity | 1960 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.