Events

Safety Alert for Wallstent Tips Endoprosthesis with Unistep Release System (WALLSTENT® Carotid with Monorail® Delivery System), ANVISA registration no. 10341350226.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific 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
    834
  • Date
    2006-07-17
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    According to Boston Scientific, so far, it has received no reports of complications or damage associated with this product disability. In addition to the batches reported in this notification, this recall does not affect any other WALLSTENT® Carotid with Monorail® Delivery System. The Unit of Technovigilance - UTVIG / NUVIG / ANVISA is monitoring the actions of the company. Voluntary Withdrawal Notification Letter: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/834_recall.pdf Verification / Traceability Form to be completed by affected clients: http://www.anvisa.gov. br / technovigilance / alerts / annexes_2006 / 834_formula.pdf
  • Reason
    As of 06/29/2006, boston scientific has received 26 claims related to the inability to irrigate the product release system at the time of rescue. the potential clinical effects associated with this complication include prolongation and delay of the clinical procedure.
  • Action
    Immediately discontinue use and segregate the units affected by this recall (the attached table provides a complete list of products affected by this recall, including codes, batch numbers, and product descriptions). List of affected products: The distribution or use of products affected by this recall must cease immediately. Corrective measures are being implemented and the replacement of the product is now available. ************************************************ Update on 08/15/2006: Boston Scientific informs that all customers have already been notified and that all affected products have already been collected. In total, 646 units of affected products were collected. http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/834_prod_afetados.pdf

Device

Wallstent Tips Endoprosthesis with Unistep Release System (WALLSTENT® Carotid with Monorail® Deli...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA