Events

Rappel de FLEXCATH STEERABLE SHEATH

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

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
    64646
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-08-09
  • 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 field notification is to inform affected customers of an observation related to a potential leak in the hemostatic valve of the flexcath 12 steerable sheath model 3fc12 and provided information on the best approach to recognize and manage the observation. in may 2011 the rate of occurrence of hemostatic valve leaking related issues rose from 0.35% to 2.47%. the reported failures are hemostatic valve leaking and air ingress during aspiration. due to the design difference of the 12 french sheath from the 10 french sheath and the increase in the rate of occurrence being specifically related to the 12 french model of the flexcath sheath the communication is being focused on the 12 french sheath model.

Device

FLEXCATH STEERABLE SHEATH
  • Modèle / numéro de série
    Model Catalog: 3FC12 (Lot serial: >10 numbers contact mfg)
  • Description du dispositif
    FLEXCATH STEERABLE SHEATH Model 3FC12
  • Manufacturer
    MEDTRONIC CRYOCATH LP

Manufacturer

MEDTRONIC CRYOCATH LP
  • Adresse du fabricant
    KIRKLAND
  • 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