Rappel de Medtronic DLP Adapters and Pressure Display Sets DLP Extension Line Adapters 20 in length, GDLP Antegrade/Retrograde Adapter, DLP Cardioplegia Adapter with Pressure Port, DLP Pressure Monitoring Extension Line Adaptors, DLP Pressure Disposable Pressure Display Sets

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class I
  • 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
    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 recently identified small pinholes approximately 1mm or less in diameter in single packaging configuration. medtronic has performed an internal investigation and all products configured and manufactured since march 1 2016 are potentially affected. this result is a potential sterile barrier breach. zero complaints have been received for the affected lots. potential patient harm is infection, which could result in secondary harm if a sterile barrier breach in the packaging is present, but not detected prior to use.
  • Action
    Medtronic is Recalling affected stock from the Market.


  • Modèle / numéro de série
    Medtronic DLP Adapters and Pressure Display SetsDLP Extension Line Adapters 20 in lengthProduct Code: 11001GDLP Antegrade/Retrograde AdapterProduct Code: 13001DLP Cardioplegia Adapter with Pressure PortProduct Code: 15004DLP Pressure Monitoring Extension Line AdaptorsProduct Codes: 25009, 25010DLP Pressure Disposable Pressure Display SetsProduct Codes: 61000, 62000ARTG Numbers: 126007 and 130994
  • Classification du dispositif
  • Manufacturer


  • 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