FDA-Device2022-07-13Class II
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Abbott
Hazard
When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
Sold states
US Nationwide distribution.
Affected count
191 devices
Manufactured in
5050 Nathan Ln N, N/A, Plymouth, MN, United States
Products
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1344-2022Don't want to check this manually?
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