FDA recall Z-2070-2021

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.

Reason for recall

Marketed without a 510K

Distribution

US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.

Key facts

Status

Ongoing

Initiation date

2021-05-19

Report date

2021-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2070-2021