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Arrow International Inc recalls Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary u
Recalled July 21, 2021 · FDA recall Z-2070-2021 · Arrow International
Hazard
Marketed without a 510K · FDA Class II
Units
4 units
Sold at
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Description
Marketed without a 510K
Product
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.
Manufacturer(s)
Arrow International Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →