Z-0912-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2013
- Initiation Date
- January 14, 2013
- Termination Date
- June 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 devices
Product Description
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.
Reason for Recall
Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Distribution Pattern
Nationwide Distribution including the states of MD, PA and TX.
Code Information
Model Number(s): MAX1 A000163, Lot Number 41865