Events

Avis De Sécurité sur Guardian® II Hemostasis Valve

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Vascular Solutions, Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Investigation of a recent complaint has made vascular solutions, inc. aware of a potential problem with the click version of our guardian ii hemostasis valve. the low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism. no air ingress or patient harm has been reported; however, due to the potential harm vsi is voluntarily recalling guardian ii hemostasis valves manufactured with the following lot number(s): .

Device

Guardian® II Hemostasis Valve
  • Modèle / numéro de série
    41817 42029 42068 42409 42410 42687 42688 42689 42691 42692 42693 42699 42700 42701 42986 42987 42988 42989 43186 43187 43188 43408 - - -
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.