U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Clip, implantable - Product Code FZP
원인
There is a potential for a component failure of the device which could necessitate medical intervention.
조치
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 AtriCure, Inc. Customers should contact AtriCure customer service at 1-866-349-2342, and select option 6 to return any affected product(s). Customers were asked to complete and return the enclosed Device Notification Acknowledgement Form as soon as possible. Customers with questions should call 513-755-4563.
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
제품 설명
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.