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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:127481

IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.

Official recall number

Z-1794-2014

Evidence summary

Product code
OAD
Recall status
Terminated
Event initiated
May 15, 2014
Root cause
Use error
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1794-2014