Rappel de Medtronic MiniMed Sure-T infusion sets

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
  • ID de l'événement
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Medtronic identified that certain minimed sure-t infusion sets had a slight increase of reported cases where the steel needle broke during use. in a small number of these reported cases, the needle break led to hospitalisation for the management of glucose levels and/or treatment for removal of the needle. since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks.
  • Action
    In the event consumers wish to carry on with using the old needle they are reminded to follow the current IFU along with specific additional instructions in the customer letter; OR if they prefer users (including members of the public) can phone Medtronic for replacement with unaffected stock. For more details, please see https://www.tga.gov.au/alert/medtronic-minimed-sure-t-infusion-sets. This action has been closed-out on 12/08/2016.


  • Modèle / numéro de série
    Medtronic MiniMed Sure-T infusion setsModel Numbers: MMT-860, MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-870, MMT-873, MMT-874, MMT-875, MMT-876, MMT-883, MMT-884, MMT-885, MMT-886ARTG # 119216
  • Manufacturer


  • Société-mère du fabricant (2017)
  • 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