Events

Rappel de MindFrame Capture LPAll

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
    Recall
  • ID de l'événement
    RC-2018-RN-00194-2
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-03-02
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00194-2
  • 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 has identified the potential for an issue with all mindframe capture lp devices to partially detach or separate from the delivery wire.
  • Action
    For affected product that has not been used, Medtronic is advising users to quarantine all unused affected product to prevent further use and return them. A Medtronic representative can assist in facilitating the return of product as necessary. In situations where the MindFrame Capture LP device stent or stent fragments have been retained, Medtronic is unable to provide specific patient management recommendations at this time due to patient variability associated with these situations. Medtronic is investigating if recommendations can be made to mitigate potential risks associated with this situation and will contact users as soon as possible when these recommendations, if any, become available.

Device

MindFrame Capture LPAll
  • Modèle / numéro de série
    MindFrame Capture LPAll Models Affected (unexpired product numbers: 300010, 300011, 300012, 300013,300014, 300015, 300016, 300017, 300018)All Lot Numbers Affected.ARTG Number: 283135(Medtronic Australasia - Mindframe Capture LP Revascularization Device - Embolectomy/thrombectomy suction catheter)
  • Classification du dispositif
    Neurological Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA