AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Reason: There is a potential for a component failure of the device which could necessitate medical intervention.

Code information: Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773

Distribution pattern: Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland