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Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Recalled October 22, 2025 · FDA recall Z-0112-2026 · Abbott
Hazard
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. · FDA Class I
Units
11810 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, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Manufacturer(s)
Abbott
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →