Class 2 Device Recall Abbott TactiFlex

• Date Initiated by Firm: December 18, 2023
• Date Posted: January 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0814-2024
• Recall Event ID: 93711
• PMA Number: P130026
• Product Classification: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
• Product: TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
• Code Information: Lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, Exp. 11/30/2024, GTIN 05415067034618.
• FEI Number: 1000139754
• Recalling Firm/ Manufacturer: St. Jude Medical, Atrial Fibrillation Division, Inc.; 1 Saint Jude Medical Dr; Saint Paul MN 55117-1789
• For Additional Information Contact: Janna Parks; 651-756-5400
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued letters dated 12/18/2023 via hand-delivery and FedEx beginning 12/18/2023. The letter explained the issue, the scope of the problem, the impact and associated risks, and next steps to help reduce risk. These steps were: (1) Do not use any remaining inventory from the affected lots listed in Appendix A; (2) Complete and return the accompanying Acknowledgment Form; (3) Return all remaining unused devices from the affected lots; and (4) Forward the letter to anyone within their organization who may need to be notified. Replacements of returned affected devices with a similar curve are available and the customer's Abbott representative can assist in returning these devices and obtaining replacements.
• Quantity in Commerce: 483 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = OAE