Events

Safety Alert for Information Update - Greenfield Filter for titanium vena cava

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific.

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
    818
  • Date
    2005-12-12
  • 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 the company, so far Boston Scientific do Brasil has not received similar notification associated with affected lots, with the company importing 243 units of affected lots, of which seven units are in "quarantine" in the company's warehouse. Updated 01/24/2006 1. The UTVIG sent correspondence to the coordinations of the Sanitary Surveillance of the Federation Units where the company mentioned the existence of clients of affected lots, with a view to reinforcing the Alert; 2. According to information provided by the company, the 75 clients that received the affected lots were contacted, of which only one had in their warehouse one unit of the affected product, which was collected on 12-13-2005.
  • Reason
    Boston scientific reported the occurrence of the release of the alloy between the carrier capsule and the outer sheath of some batches manufactured before march 10, 2004 (to see relation, go to: http: //www.Anvisa.Gov.Br/divulga/ reports / 2005 / 141205_boston.Pdf). he clarified that if the carrier capsule is detached during the procedure, there is a risk of pulmonary, coronary or carotid embolism, which could lead to serious consequences for the patient, including death. the recall does not cover filters that have already been deployed and does not also cover other types of greenfield vial filters, in addition to the specified batches (to see relation, go to: http: //www.Anvisa.Gov.Br/divulga/informes/ 2005 / 141205_boston.Pdf).
  • Action
    The Company Boston Scientific do Brasil Ltda. contacted its customers and initiated voluntary market withdrawal of the lots involved in the problem, noting that the distribution or use of affected lots should cease immediately. The verification / traceability form was submitted to clients to be completed and returned, even if the customer does not have any units of the lots involved in the voluntary recall (recall) • The following written guidelines are transcribed below: Immediately discontinue use of the recalled product and segregate it: Immediately remove all batches affected by this recall from your stock (even if the product is in the Hemodynamics, Central Customer Service, Shipping and Receiving, or elsewhere) ; segregate the product and keep it in a safe place to return it to Boston Scientific of Brazil; o Complete and return the Verification / Traceability Form: Complete the Verification / Traceability Form (even if you do not have products to return), following the instructions on this page and the Verification / Traceability Form; return the Verification / Traceability Form to Lílian Garcia Orofino - Fax (11) 5502-8508, immediately after completion, by fax and the original way with the products returned; all products affected by this recall returned to Boston Scientific of Brazil will be replaced. o Pack / Ship the product affected by this recall: Pack the products to be returned Boston Scientific do Brasil in appropriate packaging; affix the shipping label (red / white) in the shipping carton; Seal the carton and return it to Boston Scientific do Brasil - United Nations Av. 12901 - CEP 04578-910 - Brooklin Novo - São Paulo / SP.

Device

Information Update - Greenfield Filter for titanium vena cava

Manufacturer

Boston Scientific
  • Source
    ANVSANVISA