Events

Rappel de Device Recall Merci Retriever

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 Concentric Medical Inc.

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
    69119
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2598-2014
  • Date de mise en oeuvre de l'événement
    2014-06-25
  • Date de publication de l'événement
    2014-09-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129669
  • 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
    Catheter, thrombus retriever - Product Code NRY
  • Cause
    Merci retrievers were shipped to us customers past their expiration date, even though they were labeled with the correct expiration date.
  • Action
    Concentric sent an Urgent Medical Device Recall Notification dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters were sent to Risk Manager- Director of Material and requested that the subject devices be quarantined and that Concentric be notified if the product has been distributed to other organizations. If so Concentric should be notified so that the additional customers can be notified. The response form should be completed and returned to Neuro Complaints @Stryuker.com. upon receipt of the response form, a representative will contact the firm to arrange for return and/or credit for the devices. Fax it to 1-866-876-4355. For further questions please call ( 650) 810-1707 Ext. 1716.

Device

Device Recall Merci Retriever
  • Modèle / numéro de série
    Model Number 90109; Lot number 35695
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of PA, CA, TX, NM, and OH.
  • Description du dispositif
    Merci Retriever || Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
  • Manufacturer
    Concentric Medical Inc

Manufacturer

Concentric Medical Inc
  • Adresse du fabricant
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA