FDA-Device2025-10-22Class I
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Abbott
Hazard
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Sold states
Worldwide
Affected count
3404 units
Manufactured in
5050 Nathan Ln N, Plymouth, MN, United States
Products
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0110-2026Don't want to check this manually?
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