Events

Recall Or Safety Alert for Products for endovascular surgery: high pressure syringe Everest 20 atm. (batch number 50755851)

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Medtronic Inc. (plant - Medtronic Vascular), USA Medtronic Inc. (plant - Medtronic Mexico in Mexico), USA.

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 Number
    ИМ-7.96332, ИМ-7.96335
  • Date
    2014-02-26
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Extra notes in the data
  • Reason
    In connection with the incorrect labeling of the product, the manufacturer sent letters to all consumers about the events to be carried out when using the specified batch of high-pressure syringes everest 20 atm. (batch number 50755851), and the need to contact your medtronic distributor. the number of sold products was 191 pcs. according to the data in the letter to medtronic, the products were sold in the united states in 6 states: texas, maine, iowa, pennsylvania, oregon and new hampshire.

Device

Products for endovascular surgery: high pressure syringe Everest 20 atm. (batch number 50755851)

Manufacturer

Medtronic Inc. (plant - Medtronic Vascular), USA Medtronic Inc. (plant - Medtronic Mexico in Mexi...
  • 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
    MHRB