Events

Rappel de Device Recall Stryker brand Neuroform 3 Microdelivery Stent System

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 Stryker 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
    65654
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1808-2013
  • Date de mise en oeuvre de l'événement
    2013-06-24
  • Date de publication de l'événement
    2013-07-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119819
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    intracranial neurovascular stent - Product Code NJE
  • Cause
    The device is labeled incorrectly, in that, the device model number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. the model number on the outer box states upn m003e345020 (4.5mm x 20 mm neuroform 3 stent) while the pouch label states upn m003e3450300 (4.5mm x 30 mm neuroform 3 stent).
  • Action
    Stryker Neurovascular sent an Urgent Field Safety Notice on June 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their internal inventory and quarantine all subject devices pending return to Stryker. Circulate the Field Safety Notice internally to all interested/affected parties. Maintain awareness of this notice internally until all requred actions have been completed within their facility. Inform Stryker if any of the subject devices were distributed to other organization. Complete the attached customer response form and return to their Stryker Representataive. For questions regarding this recall call 510-413-2500.

Device

Device Recall Stryker brand Neuroform 3 Microdelivery Stent System
  • Modèle / numéro de série
    Code: M003450200, Lot 15391019, Expiration Date: 2015-07
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    HDE
  • Dispositif implanté ?
    Yes
  • Distribution
    International Distribution including Austria, China, and Germany.
  • Description du dispositif
    Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA || The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Adresse du fabricant
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA