Events

Rappel de EMPRINT PERCUTANEOUS ANTENNA WITH THERMOSPHERE TECHNOLOGY LARGE SPHERICAL ABLATION ZONE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COVIDIEN LLC.

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
    59398
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-02-25
  • 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
    This recall is being conducted following customer reports of the emprint ablation generator shutting down due high temperature measurements in the emprint percutaneous antenna. if the generator shuts down due to elevated temperature readings at the antenna tip the antenna must be replaced and the ability to tract ablate is limited.

Device

EMPRINT PERCUTANEOUS ANTENNA WITH THERMOSPHERE TECHNOLOGY LARGE SPHERICAL ABLATION ZONE
  • Modèle / numéro de série
    Model Catalog: CA30L1 (Lot serial: >10 CONTACT MFR); Model Catalog: CA15L1 (Lot serial: >10 CONTACT MFR); Model Catalog: CA20L1 (Lot serial: >10 CONTACT MFR)
  • Description du dispositif
    EMPRINT PERCUTANEOUS ANTENNA WITH THERMOSPHERE TECHNOLOGY
  • Manufacturer
    COVIDIEN LLC

Manufacturer

COVIDIEN LLC
  • Adresse du fabricant
    MANSFIELD
  • 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