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

Recall date

September 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0112-2026

FDA classification

Class I

Brand / firm

Abbott

Sold / distributed

Worldwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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