Events

Rappel Ou Alerte De Sécurité sur Products for endovascular surgery: high pressure syringe Everest 20 atm. (batch number 50755851)

Selon Ministry of Health of the Republic of Belarus, ce/cet/cette rappel ou alerte de sécurité concerne un dispositif en/au/aux/à Belarus qui a été fabriqué par Medtronic Inc. (plant - Medtronic Vascular), USA Medtronic Inc. (plant - Medtronic Mexico in Mexico), USA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Safety alert
  • Numéro de l'événement
    ИМ-7.96332, ИМ-7.96335
  • Date
    2014-02-26
  • Pays de l'événement
    Belarus
  • Source de l'événement
    MHRB
  • URL de la source de l'événement
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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