FDA-Device2025-10-22Class I
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Hazard
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Sold states
Worldwide
Affected count
407 units
Manufactured in
5050 Nathan Ln N, Plymouth, MN, United States
Products
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2026Want us to check the next one for you?
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