# FDA recall Z-0814-2024

> **St. Jude Medical, Atrial Fibrillation Division, Inc.** · Class II · device recall initiated 2023-12-18.

## 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.

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DC, DE, FL, GA, IA, IL, KS, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, and WV. The country of Canada.

## Key facts

- **Recall number:** Z-0814-2024
- **Recalling firm:** St. Jude Medical, Atrial Fibrillation Division, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-18
- **Report date:** 2024-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0814-2024

## Citation

> AI Analytics. FDA recall Z-0814-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0814-2024. Source: US FDA. Licensed CC0.

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