Events

Rappel de SYMPLICITY RENAL DENERVATION CATHETER

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
    Recall
  • ID de l'événement
    17440
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-01-24
  • 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
    Medtronic has identified an issue with the symplicity model rdn006 catheter cable connectors which may prevent therapy delivery. the symptoms include: o a flickering generator display screen upon initial catheter connection o generator status display of "check connection" o rapid fluctuations in the temperature reading o multiple early termination of energy delivery accompanied by "check status" safety codes 22 23 and/or 32 despite confirming electrode placement as defined by the ifu. this issue is isolated to the catheter and does not impact the rf generator. medtronic is distributing this notification to inform of methods to detect the failure and guidance to minimize inconveniences.

Device

SYMPLICITY RENAL DENERVATION CATHETER
  • Modèle / numéro de série
    Model Catalog: RDN006 (Lot serial: > 10 lot numbers contact mfg)
  • Description du dispositif
    SYMPLICITY RENAL DENERVATION CATHETER
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Adresse du fabricant
    BRAMPTON
  • 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