Events

Rappel de CURVED TIP WIRE-REINFORCED AORTIC ARCH CANNULA

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

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
    27386
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2017-06-26
  • 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
    During inspection of product in its inventory sorin has identified that plastic flash may be present on the tip of the aortic arch cannulae. there is a risk that flash can become detached during cardiac surgery and be released into the patient's blood circulation resulting in the possibility of embolism. to mitigate this hazard sorin is removing these affected aortic arch cannulae from the marketplace and replacing them with new aortic cannulae which have been verified not to contain flash.

Device

CURVED TIP WIRE-REINFORCED AORTIC ARCH CANNULA
  • Modèle / numéro de série
    Model Catalog: RA-1137 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: NA-1337 (Lot serial: 1700300233); Model Catalog: NA-001TG (Lot serial: 1519500072); Model Catalog: NA-1337 (Lot serial: 1617900116); Model Catalog: NA-1337 (Lot serial: 1611700045); Model Catalog: NA-1337 (Lot serial: 1608800130); Model Catalog: NA-1337 (Lot serial: 1607500029); Model Catalog: NA-1337 (Lot serial: 1530000132); Model Catalog: NA-1337 (Lot serial: 1528600115); Model Catalog: NA-001TG (Lot serial: 1701600204); Model Catalog: NA-001TG (Lot serial: 1634000158); Model Catalog: NA-001TG (Lot serial: 1629800189); Model Catalog: NA-001TG (Lot serial: 1627100070); Model Catalog: NA-001TG (Lot serial: 1623600028); Model Catalog: NA-001TG (Lot serial: 1611700043); Model Catalog: NA-001TG (Lot serial: 1528600113); Model Catalog: NA-1337 (Lot serial: 1620000013)
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    AORTIC ARCH CANNULAE RA-1137;AORTIC ARCH CANNULAE NA-1337;AORTIC ARCH CANNULAE NA-001TG
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    HC