Events

Rappel de Device Recall Penumbra 3D Revascularization Device

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 Penumbra 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
    77571
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2702-2017
  • Date de mise en oeuvre de l'événement
    2017-06-09
  • Date de publication de l'événement
    2017-06-22
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156554
  • 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
    Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. this issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.
  • Action
    Penumbra sent an Urgent Voluntary Field Removal Notice dated June 9, 2017. Customers were instructed to inspect current inventory and remove any affected units for return. Customers were also instructed to return the response form. Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death. Penumbra personnel will contact customers directly to arrange return of affected units and replacement of returned product at no charge to them. Customers with question should call 1-510-748-3288.

Device

Device Recall Penumbra 3D Revascularization Device
  • Modèle / numéro de série
    Lots C00644, C00645, C00646, C00717
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV
  • Description du dispositif
    Penumbra 3D Revascularization Device || It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
  • Manufacturer
    Penumbra Inc.

Manufacturer

Penumbra Inc.
  • Adresse du fabricant
    Penumbra Inc., 1 Penumbra, Alameda CA 94502-7610
  • Société-mère du fabricant (2017)
    Penumbra, Inc.
  • Source
    USFDA