Recall Z-0110-2026— Abbott

Name: FDA recall Z-0110-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-10

Class I · Ongoing

Class I FDA medical device recall by Abbott, initiated 2025-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter. Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging..

Recalling firm: Abbott
Classification: Class I
Status: Ongoing
Initiated: 2025-09-10
Firm location: Plymouth, MN, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.