TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

FDA device recall Z-0814-2024 · posted 2024-01-25 · Open, Classified

Recall details

Recalling firm

St. Jude Medical, Atrial Fibrillation Division, Inc.

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.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OAE

Quantity affected

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. Th

Date initiated

2023-12-18

Date posted

2024-01-25

Location

Saint Paul, MN