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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:187934

Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

Official recall number

Z-2070-2021

Evidence summary

Product code
N/A
Recall status
Open, Classified
Event initiated
May 19, 2021
Root cause
No Marketing Application
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2070-2021