Recall Z-0377-2017 ยท FZP Clip, Implantable
AtriCure, Inc.
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.
| Date | Sep 22, 2016 |
| Status | Terminated |
| Reason | There is a potential for a component failure of the device which could necessitate medical intervention. |
| Root cause | Device Design |
| Action | AtriCure sent an Urgent Advisory Notice dated September 21, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and determine if they have any affected product. If so customers should ensure that all users of the affected devices are aware of the Advisory Notice. If customers further distributed the product, they should identify their customers and notify them at once of the Advisory Notice. Any units from the affected lots should be returned to AtriC |
| Quantity | 298 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip AtriCure, Inc., Mar 18, 2016 |