Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

Recalled October 22, 2025 · FDA recall Z-0113-2026 · Abbott

Hazard

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. · FDA Class I

Units

1960 units

Sold at

Worldwide

Description

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Product

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

Manufacturer(s)

Abbott

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →