St. Jude Medical, Atrial Fibrillation Division, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0814-2024Class IITactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal December 18, 2023