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U.S. Department of Health and Human Services

Class 2 Device Recall Isolator Linear Pen, Electrosurgical cutting and coagulation device and accessories

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  Class 2 Device Recall Isolator Linear Pen, Electrosurgical cutting and coagulation device and accessories see related information
Date Initiated by Firm January 14, 2013
Date Posted March 06, 2013
Recall Status1 Terminated 3 on June 11, 2013
Recall Number Z-0912-2013
Recall Event ID 64404
510(K)Number K050459  K061593  
Product Classification Surgical device, for ablation of cardiac tissue - Product Code OCL
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.
Code Information Model Number(s): MAX1 A000163, Lot Number 41865
Recalling Firm/
Manufacturer		 Atricure Inc
6217 Centre Park Drive
West Chester OH 45069
For Additional Information Contact James L. Lucky
513-755-4100
Manufacturer Reason
for Recall		 Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
FDA Determined
Cause 2		 Employee error
Action AtriCure sent a Urgent Medical Device Recall/Correction letter dated January 14, 2013, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. If the MAX1 is used as intended there is no risk to the patient as a result of this issue. The correct instructions for Use for the MAX1 Pen is included with this notification. AtriCure will replace any affected product if requested by the facility. Please review and fill out the attached " Acknowledgement Form" and either fax to AtriCure at (513) 644-4753. If you need to contact customer service, their number is 1-866-349-2342.
Quantity in Commerce 5 devices
Distribution Nationwide Distribution including the states of MD, PA and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OCL and Original Applicant = ATRICURE, INC.
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