Rappel de HeartWare Vetricular Assist Device AC Adapters and batteries

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 International 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
  • ID de l'événement
  • 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
    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: Auckland District Health Board (Health Alliance), CDC Dept Level 4 Health Alliance Building, Auckland City Hospital, Park Road, Grafton, Auckland
  • Cause
    As part of heartware's ongoing product performance monitoring, we have reviewed certain complaints related to the hvad® system and are distributing this notice to announce (i) a voluntary recall of ac adaptors designed for 220-volt power grids; and (ii) a voluntary recall of certain older batteries more likely to exhibit deterioration of battery capacity. heartware believes that these actions will help reduce the occurrence of avoidable injuries as patients remain on the device for increasingly long periods of time., new field action - dec2015a (hvad controller ac adaptors):, o heartware fsca dec2015a is assigned to product code: 1430xx; serial numbers: cac000001 to cac005796; reason: heartware ac adapters are vulnerable to power grid surges above 220 volts.
  • Action
    Manufacturer to issue advice regarding use



  • 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