St. Jude Medical, Atrial Fibrillation Division, Inc. recalls TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

Recall date

December 18, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0814-2024

FDA classification

Class II

Brand / firm

St. Jude Medical, Atrial Fibrillation Division, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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