TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
This recall is currently active, issued January 25, 2024. It was issued by St. Jude Medical, Atrial Fibrillation Division, Inc..
- Recall Initiated
- December 18, 2023
- Posted
- January 25, 2024
- Recall Number
- Z-0814-2024
- Quantity
- 483 units
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, Exp. 11/30/2024, GTIN 05415067034618.
Root Cause
Under Investigation by firm
Action Taken
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.