FDA Device recall Z-0814-2024
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile by St Jude Medical Atrial Fibrillation Division, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0814-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-18 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | St Jude Medical Atrial Fibrillation Division |
| Distribution | US |
Product
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Reason
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.
Identifiers
| code_info | Lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, Exp. 11/30/2024, GTIN 05415067034618. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0814-2024%22
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