FDA-Device2024-01-31Class II
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
St. Jude Medical, Atrial Fibrillation Division, Inc.
Hazard
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.
Sold states
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.
Affected count
483 units
Manufactured in
1 Saint Jude Medical Dr, N/A, Saint Paul, MN, United States
Products
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0814-2024Don't want to check this manually?
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