TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Reported: January 31, 2024 Initiated: December 18, 2023 #Z-0814-2024
Product Description
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
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.
Details
- Recalling Firm
- St. Jude Medical, Atrial Fibrillation Division, Inc.
- Units 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. The country of Canada.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.. Recalled by St. Jude Medical, Atrial Fibrillation Division, Inc.. Units affected: 483 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 31, 2024. Severity: Moderate. Recall number: Z-0814-2024.
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