Events

Recall Or Safety Alert for ONYX Liquid Embolic System

According to Central Drugs Standard Control Organization, this recall or safety alert involved a device in India that was produced by Covidien Healthcare India Pvt. Ltd..

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
    Recall / Safety Alert
  • Event ID
    31-51A-MD/2006-DC (Re-Reg 2011)
  • Date
    2013-12-10
  • Event Country
    India
  • Event Source
    CDSCO
  • Event Source URL
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notes / Alerts
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • Extra notes in the data
  • Reason
    Recall of "onyx liquid embolic system" due to catheter entrapment, which could lead to breakage haemorrhage and possibly death.

Device

ONYX Liquid Embolic System

Manufacturer

Covidien Healthcare India Pvt. Ltd.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    CDSCO