St. Jude Medical, Atrial Fibrillation Division, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0814-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

Product Classification:

Class II

Date Initiated: December 18, 2023

Date Posted: January 31, 2024

Recall Number: Z-0814-2024

Event ID: 93711

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.

Status: Ongoing

Product Quantity: 483 units

Code Information:

Lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, Exp. 11/30/2024, GTIN 05415067034618.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated