Alerta De Seguridad para HYDROFILIC COVERING PTCA GUIDE FOR PTCA

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.

Boston Scientific does the following guidelines: Immediately discontinue use and segregate affected units. - Immediately remove all affected batches from your inventory, rooms for special procedures, interventional radiology, OR, hemodynamics, central service, dispatch, receipt or any other location. - Segregate the affected units in a safe place and return them to Boston Scientific of Brazil. - All returned products will be replaced. The distribution or use of any remaining product affected should be terminated immediately. The Company further clarifies that this action does not affect any other PT2 Guide Wire in addition to the lots reported. To view the list of affected lots, go to: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/842.pdf UPDATE: 491 affected units of the product were collected in Brazil and sent to the Boston distribution center Scientific Corporation located in Quincy, United States, on November 14, 2006, as proof of re-export filed by the company.