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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Lake Region Medical Limited; Abbott Laboratórios do Brasil LTDA..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Possibility of partial lamination of the ptfe coating, with risk of embolism, thrombi and occlusion of the peripheral veins.
  • Action
    Abbot Vascular is collecting the product from the market. Check your inventory and segregate the identified risk products. Contact the company for return purposes.