Safety Alert for CATETER GUIDER SOFTIP GUIDE - Registered in Anvisa under the number 10341350444 - Lots as listed in the appendix.

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.

This action in the field follows the Safety Alert issued by Boston Scientific on October 6, 2009. Boston Scientific is taking this additional action after consulting the United States Department of Food and Drug Administration. The original Safety Alert informed users about the potential for degradation of a distal section of the catheter after exposure to UV light (eg sunlight) or fluorescent light (eg office light) and reminded them to store the according to the instructions for use, namely, "Store the catheters in a cool, dry and dark area." If stored in your box and used in accordance with the Instructions for Use, the Guider Softip Guide Catheter will to the performance specifications throughout the validity period indicated on the labeling. If exposed to ultraviolet light or fluorescent light out of the box during the storage period, a portion of the catheter may degrade, which could adversely affect the performance of the device and potentially expose patients to serious risks, including delay at the time of the procedure, due to catheter replacement, vascular trauma and apoplexy. Therefore, DO NOT USE any Guider catheters that have been stored out of the box. Boston Scientific is conducting voluntary recall for all products from customers outside the United States. Anvisa is following this action. Please refer to the attached list of Affected Products. The Guider catheters listed in the attachment should be returned for replacement. #### Update: The field action (recall) was terminated in January 2009, as communicated by UTVIG (on 01/26/2011) of Boston Scientific do Brasil Ltda. The company sold 7,165 units of the product in Brazil and collected 341 units (4.6%), which were sent to the distribution center in the United States of America, according to the documentation sent by the company.