Class I

Medical Device Recall: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

Abbott · September 10, 2025

Reason for Recall

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

Distribution

Worldwide

Quantity Affected

3404 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0110-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.