Home / Recalls / Medical Devices
AtriCure, Inc. recalls AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's le
Recalled November 16, 2016 · FDA recall Z-0377-2017 · AtriCure
Hazard
There is a potential for a component failure of the device which could necessitate medical intervention. · FDA Class II
Units
298
Sold at
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
Description
There is a potential for a component failure of the device which could necessitate medical intervention.
Product
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.
Manufacturer(s)
AtriCure, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →