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Health Canada Medical devices

Tacticath Contact Force Ablation Catheter, Sensor Enabled

Issued July 4, 2022
Issue
Abbott is voluntarily recalling affected lots of the Tacticath Contact Force Ablation Catheter, Sensor Enabled (models A-TCSE-DF and A-TCSE-DD). In certain instances, the Tacticath Contact Force Ablation Catheter, Sensor Enabled generates an error when initially connected to the Tactisys that states the "contact force catheter is intended for single use only" and disables contact force sensing for affected catheters. Recall start date: March 24, 2022
Hazard description
Performance
Product
Product name
Tacticath Contact Force Ablation Catheter, Sensor Enabled
Reference
ID
RA-64328