Events

Safety Alert for Bioenterics Integastric Ballon BIB SYSTEM and ORBERA APOLLO

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Apollo Endosurgery, Inc. || Apollo Endosurgery Costa Rica, S.R.L || Allergan || Apollo Endosurgery, 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
    I1805-288
  • Event Number
    2012DM-0009222
  • Date
    2018-05-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=47
  • 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

Device

Bioenterics Integastric Ballon BIB SYSTEM and ORBERA APOLLO
  • Model / Serial
    BIB (B-40800), ORBERA (B-50000) and ORBERA365 (B50012)
  • Product Description
    It is indicated for temporary use in weight loss therapies for patients whose obesity carries significant health risks and who have not managed to maintain a weight loss with a supervised weight control program. The maximum period of placement of the BIB system is 6 months and must be withdrawn once this term is completed or before.
  • Manufacturer
    Apollo Endosurgery, Inc. || Apollo Endosurgery Costa Rica, S.R.L || Allergan || Apollo Endosurgery, Inc

Manufacturer

Apollo Endosurgery, Inc. || Apollo Endosurgery Costa Rica, S.R.L || Allergan || Apollo Endosurger...
  • Source
    NIDFSINVIMA