Events

Avis De Sécurité sur LeVeen Needle Electrodes – 5.0cm

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Boston Scientific.

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
  • Date
    2009-08-14
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/leveen-needle-electrodes-5.0cm---important-safety-information-from-boston-scientific&id=60d1f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
  • Notes supplémentaires dans les données
    3rd Party Publications
  • Cause
    Background information or related documents: boston scientific corporation is conducting a medical device recall of the leveen™ needle electrodes – 5.0cm. boston scientific has become aware that during a procedure, the umbrella of the leveen™ needle electrode – 5.0cm may become detached from the core wire. the potential clinical effects of this product issue are bleeding or soft tissue trauma which may require intervention. to date there has been one reported complaint for this issue. further information is available in the field safety notice below. important safety information - leveen needle electrodes – 5.0cm.

Device

LeVeen Needle Electrodes – 5.0cm
  • Modèle / numéro de série
  • Description du dispositif
    LeVeen Needle Electrodes – 5.0cm - Important Safety Information from Boston Scientific
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    HPRA