Recall Z-0814-2024 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
St. Jude Medical, Atrial Fibrillation Division, Inc.
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
| Date | Jan 25, 2024 (initiated Dec 18, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.