FDA Device recall Z-1344-2022
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during abla…
- FDA Device
- Class II
- terminated
- Published 2022-07-13
On 2022-07-13 the FDA classified a Class II recall of Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during abla… by Abbott, citing when connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1344-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-09 |
| Published | 2022-07-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott |
| Distribution | US |
Product
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Reason
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."
Identifiers
| code_info | UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1344-2022%22
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