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 initiating this voluntary recall because strata mr valve may experience a condition that may in limited circumstances affect the flow resistance in the valve and result in underdrainage of cerebrospinal fluid (csf). the recall is based on an issue impact assessment where an increase in the complaint rate related to incorrect flow was noted for the strata mr product family which indicated that current residual risk for strata mr products is undesirable and requires additional mitigations to reduce risk. this condition may result in the following adverse health consequences: headaches nausea vomiting and lethargy. if left untreated underdrainage has the potential to lead to coma and death.


  • Modèle / numéro de série
    Model Catalog: 42965 (Lot serial: E18556); Model Catalog: 42955 (Lot serial: E18556); Model Catalog: 42965 (Lot serial: E13698); Model Catalog: 42955 (Lot serial: E13698); Model Catalog: 42965 (Lot serial: E12951); Model Catalog: 42955 (Lot serial: E12951)
  • Classification du dispositif
  • Description du dispositif
  • 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