Device Recall Isolator Linear Pen, Electrosurgical cutting and coagulation device and accessories

Model Number(s): MAX1 A000163, Lot Number 41865

Cardiovascular Devices

2

No

Nationwide Distribution including the states of MD, PA and TX.

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.