TactiFlex Ablation Sensor Enabled Ablation Catheter — Class II medical device recall Z-0814-2024
Ongoing recall by St. Jude Medical, Atrial Fibrillation Division, Inc., reported 2024-01-31, distributed nationwide. When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter a
| Recall number | Z-0814-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Atrial Fibrillation Division, Inc., Saint Paul, MN, United States |
| Recall initiated | 2023-12-18 |
| Classified | 2024-01-25 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 483 units |
| UPC / GTIN / UDI-DI | 05415067034618 |
| Lot numbers | 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, 10095363 |
| Model numbers | 7.5F |
| Expiration dates | 2024-11-30 |
Product
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0814-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.