Safety Alert for HI-TORQUE CONNECT GUIDE WIRE and HI-TORQUE CONNECT 250T GUIDE WIRE. ANVISA Register: 80146501827 and 80146501812. Models at Risk: 1012587,1012588,1012589,1012590,1012591,1012592 / 1012593, 1012594 and 1012595. All batches available.

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.

Abbott Vascular is initiating a voluntary Field Safety Corrective Action for the HT Connect Guide Wires peripheral wire family because a small number of devices present a partial lamination of the PTFE coating. To date, the frequency of reported incidents was 0.08%. Although no long-term or irreversible effects have been reported in patients, the potential risks associated with coating lamination include: embolism, thrombus and occlusion of the peripheral veins. Abbott Vascular research is underway and there is no definite root cause identified for inadequate adhesion of PTFE coating to some guidewires. During continued research, Abbott Vascular is identifying improvements in the coating process to ensure adhesion of PTFE coating. As the event was reported on a low frequency but randomly distributed among the manufactured batches that were distributed since the product's overseas launch in September 2011, Abbott Vascular requests that customers identify and return all HI family wires -TORQUE CONNECT GUIDE WIRE not used, regardless of batch number. #### Update (02/18/2014): According to a report sent by the company, 454 units of the product have already been collected until the date of 02/13/2014.