Events

Rappel de HeartWare Sterile Surgical Tool Sets (Supplied as part of the HeartWare Ventricular Assist System, artifical heart (HVAS))

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

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-2012-RN-01040-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2012-10-31
  • 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-2012-RN-01040-1
  • 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
    There is an error with labelling regarding the “use by date” of sterile surgical tool products (ref. cat # 1318). more specifically, some units were labelled with a “use by date” corresponding to 2-years shelf life instead of the approved 1-year shelf life.
  • Action
    The sponsor is advising users of changes to the approved use by date and is asking users to inspect current inventory and amend the use by dates of affected products.

Device

HeartWare Sterile Surgical Tool Sets (Supplied as part of the HeartWare Ventricular Assist System...
  • Modèle / numéro de série
    HeartWare Sterile Surgical Tool Sets (Supplied as part of the HeartWare Ventricular Assist System, artifical heart (HVAS))Catalogue Number: 1318Lot Number: 520863ARTG Number: 181875
  • Manufacturer
    Heartware Pty Limited

Manufacturer

Heartware Pty Limited
  • 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