Device evidence

device-recall:cfres:205276

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

Official recall number

Z-0814-2024

Evidence summary

Product code: OAE
Recall status: Open, Classified
Event initiated: December 18, 2023
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0814-2024