TactiFlex Sensor Enabled recallZ-0814-2024 · St. Jude Medical, Atrial Fibrillation Division, Inc. · initiated Dec 18, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from St. Jude Medical, Atrial Fibrillation Division, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0814-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 18, 2023
- Posted by the FDA
- Jan 25, 2024
- Recalling firm
- St. Jude Medical, Atrial Fibrillation Division, Inc.
- Quantity
- 483 units
- Product code
- OAE
- FDA submissions
- P130026
- 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.
Product description
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Code information (models, lots, serial numbers)
Lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, Exp. 11/30/2024, GTIN 05415067034618.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TactiFlex™ Sensor Enabled™ A-TFSE-FJSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation2 recalls2 deaths37 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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