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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Event Detail

Event ID 64404
Product Type Devices
Status Ongoing
Recalling Firm Atricure Inc
City West Chester
State OH
Country US
Recall Initiation Date 2013-01-14
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including the states of MD, PA and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Atricure Inc. The Isolator Transpolar Pen is intended 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. Model Number(s): MAX1 A000163, Lot Number 41865 Class II AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. 5 devices Z-0912-2013