Brand
St. Jude Medical, Atrial Fibrillation Division, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for St. Jude Medical, Atrial Fibrillation Division, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-01-31FDA-DeviceClass IITactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
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.
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