Events

Rappel de Heartware Ventricular Assist Device (HVAD) DC Adapters

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Heartware Inc.

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
    22073
  • Date de mise en oeuvre de l'événement
    2017-10-10
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Cause
    As described in previous hazard alerts from april 2015 and april 2016, there was the potential for the following safety issues associated with the current heartware hvad system controller, including:, 1. worn alignment guides, potentially resulting in damaged connector pins., 2. internal double disconnect (no power) alarm battery failure, which could prevent the controller from sounding an alarm in the event of a complete interruption of power., 3. loose power and data connectors, which could allow fluid ingress, with the introduction of the updated hvad controller, also referred to as controller 2.0, medtronic is initiating removal procedures for previous generation heartware hvad controllers and all heartware dc adapters, which are incompatible with the new hvad controller. the removal of these hvad controllers and dc adapters will occur concurrently with the introduction of the new hvad controller.
  • Action
    Product to be returned to supplier

Device

Heartware Ventricular Assist Device (HVAD) DC Adapters

Manufacturer

Heartware Inc
  • 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
    NZMMDSA