FDA-Device2013-03-13Class II
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Atricure Inc
Hazard
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Sold states
Nationwide Distribution including the states of MD, PA and TX.
Affected count
5 devices
Manufactured in
6217 Centre Park Drive, N/A, West Chester, OH, United States
Products
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0912-2013Don't want to check this manually?
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