Events

Safety Alert for CVI angiographic injection system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Acist Medical Systems, Inc..

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
    R1512-592
  • Event Number
    2013EBC-0010276
  • Date
    2015-12-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=163
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer informs that it has detected that air entrances were presented in one of the two collectors of the referenced device; in a preventive manner, it has initiated the withdrawal of the potentially involved lots.

Device

CVI angiographic injection system
  • Model / Serial
    BT2000 and CPT2000, specific lots.
  • Product Description
    The ACIST injection system is an angiographic injection system that provides radiopaque contrast media with a variable flow and volume defined by the medical staff. The system has been designed for the controlled perfusion of radiopaque contrast media (not included in this application) in angiographic procedures.
  • Manufacturer
    Acist Medical Systems, Inc.

Manufacturer

Acist Medical Systems, Inc.
  • Manufacturer Parent Company (2017)
    Bracco Spa
  • Source
    NIDFSINVIMA