Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDTRONIC OF CANADA 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
  • Date de mise en oeuvre de l'événement
  • Pays de l'événement
  • Source de l'événement
  • 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
    Medtronic is mailing a safety notification to physicians associated with the synchromed infusion pump. this notification provides important information on medtronic neuromodulation's continuing efforts to investigate and communicate the impact of unapproved drugs on the performance of the synchromed infusion pump system. it includes information on motor gear corrosion which has been identified as the primary contributor to pump motor stall in the synchromed ii and synchromed el pumps. this communication is intended to reinforce with healthcare professionals the importance of following the labeling with respect to the use of indicated drugs. all active implanting or managing physicians associated with the synchromed drug infusion pump are in scope for this communication.


  • Modèle / numéro de série
    Model Catalog: 8637 (Lot serial: All Lots); Model Catalog: 8626L (Lot serial: All Lots); Model Catalog: 8627L (Lot serial: All Lots); Model Catalog: 8627 (Lot serial: All Lots); Model Catalog: 8626 (Lot serial: All Lots)
  • Classification du dispositif
  • Description du dispositif
    SynchroMedr II Implantable Drug Infusion Pump
  • Manufacturer


  • Adresse du fabricant
  • 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