Events

Rappel de Silver Speed Hydrophilic Guidewire

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par EV3 Neurovascular.

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
    37821
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0839-2007
  • Date de mise en oeuvre de l'événement
    2007-04-05
  • Date de publication de l'événement
    2007-06-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51634
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    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 data.
  • Notes supplémentaires dans les données
    vascular catheter guidewire - Product Code MKI
  • Cause
    Two customer complaints were received from physicians in japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.
  • Action
    A recall plan was developed for 100% recovery of guidewires within affected lot numbers. The plan includes notification to U.S., European, and Rest-of-World customers and distributors. A recall notification letter was prepared 04/05/2007 which summarizes the coating problem and potential risks, identifies the affected lot numbers and quantities shipped to the customer, and provides instructions for return of unused guidewires.

Device

Silver Speed Hydrophilic Guidewire
  • Modèle / numéro de série
    US: Lot # : 2295725; 2382836; 2355074; 2390635; 2348116; 2355074; 2374619; 2216295; 2257803;2390635; 2342166; ;2390635;2348116; 2310664; 2382836; 2257803; 2216295; 2310664; 2390635; 2247199; 2247200; 2221847; 2247200; 2295725; 2310664; 2221845; 2310664; 2216296; 2257803; 2342166;   European Union & Rest-Of-World Lot #:  2374619 ; 2209708;2216295; 2247200; 2310664; 2348116; 2221845 ; 2355074; 2247200; 2310664; 2216295; 2166877; 2247199; 2209708; 2367901; 2370509; 2374619; 2216295; 2163496; 2174470; 2295725; 2370509; 2376907; 2209708; 2295725; 2310664; 2221845; 2247200; 2216291; 2390635; 2360938; 2370509; 2376907; 2310664; 2355074; 2163496; 2276405; 2370508; 2221847; 2257803; 2390635; 2257803; 2370509; 2200727;
  • Classification du dispositif
    Cardiovascular Devices
  • Distribution
    Worldwide, including USA, Italy, United Kingdom, Switzerland, Germany, Belgium, South Africa, Canada, Slovenia, China, Austria, France, Spain, Jordan, Mexico, Portugal, Colombia, Greece, Brazil, Venezula, Ireland, Australia, Malaysia, Saudi Arabia, South Korea, Lithuania, Netherlands, Hungary, and United Arab Emirates
  • Description du dispositif
    Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
  • Manufacturer
    EV3 Neurovascular

Manufacturer

EV3 Neurovascular
  • Adresse du fabricant
    EV3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-2054
  • Source
    USFDA