Alerta De Seguridad para Misago Self-expanding Peripheral Stent ### Technical Name: Misago Self-Expansion Peripheral Stent ### Registration Number ANVISA: 80012280143 ### Risk Class: III (High Risk) ### ) affected: ALL ### Lot (s): EVERYTHING AND ANY LOT MANUFACTURED SINCE 2013

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

(1). Customers should discontinue use immediately, and quarantine any available inventory products of batch numbers / product codes attached. (2). Distributors should stop immediately distributing any of the batch numbers / codes from the enclosure, quarantine any available inventory, and send this recall notice immediately to each customer who received these products to inform them of this problem. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link