medical Class II Updated 2022-07-13

Abbott recalls Abbott TactiCath Sensor Enabled, Contact Force Ablation Cath

Recalled Product

Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.


Hazard / Issue

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."

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811
View official government recall

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