Events

Rappel de HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD PUMP IMPLANT KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada 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
    25742
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2013-02-11
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    The rear portion of the hvad pump's driveline connector housing becomes partially seperated or fully separated from the front portion of the driveline connector.

Device

HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD PUMP IMPLANT KIT
  • Modèle / numéro de série
    Model Catalog: (Lot serial: Serial #HW001-HW3827); Model Catalog: (Lot serial: Serial #HW10000-HW10675)
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    HeartWare HVAD Pump Implant Kit
  • Manufacturer
    HEARTWARE INC.

Manufacturer

HEARTWARE INC.
  • Adresse du fabricant
    MIAMI LAKES
  • 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
    HC