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Atricure Inc recalls Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery usi
Recalled March 13, 2013 · FDA recall Z-0912-2013 · Atricure
Hazard
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. · FDA Class II
Units
5 devices
Sold at
Nationwide Distribution including the states of MD, PA and TX.
Description
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Product
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.
Manufacturer(s)
Atricure Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →