Events

Safety Alert for Brand Name: STARCLOSE SE VASCULAR CLOSURE SYSTEM Technical Name: Vascular Suture ANVISA Registration Number: 80146501477 Hazard Class: IV Model Affected: Serial Numbers Affected: 5020141; 6041941; 6051141; 6051341

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

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
    2170
  • Date
    2017-02-07
  • 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
    Abbott Vascular will inform / request customers who received units from those lots: • check the list of affected lots on the customer's chart; • The use of devices of the indicated batches should be discontinued immediately; • Review stock and complete the effectiveness check form; • Return all identified products that have not been used to Abbott Vascular. • Share this information with relevant people in your organization; • This action does not affect patients who have successfully undergone cardiac or endovascular procedures using the StarClose SE Vascular Closure System.
  • Reason
    Abbott vascular has identified that indicated batches of the starclose se product may have difficulty or failure to deploy the starclose se clip.
  • Action
    Field Action Code February 10, 2017 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will collect.

Device

Brand Name: STARCLOSE SE VASCULAR CLOSURE SYSTEM Technical Name: Vascular Suture ANVISA Registrat...

Manufacturer

Abbott Laboratórios do Brasil LTDA; Abbott Vascular
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA