St. Jude Medical, Atrial Fibrillation Division, Inc. recalls TactiFlex Ablation Sensor Enabled Ablation Catheter, Models
Recalled Product
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Hazard / Issue
When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.
Issued by
FDA
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