Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
- Recall date
- September 10, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0113-2026
- 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, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
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